Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Intraoperative wound irrigation to prevent surgical site infection after laparotomy

    Summary
    EudraCT number
    		 2017-000152-26
    Trial protocol
    		 DE  
    Global end of trial date
    03 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jan 2023
    First version publication date
    19 Jan 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IOW-1755-REI-0540-I
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Technische Universität München, Fakultät für Medizin
    Sponsor organisation address
    Ismaninger Str. 22, München, Germany, 81675
    Public contact
    Prof. Dr. Daniel Reim, Klinikum rechts der Isar der Technischen Universität München Department of Surgery, 0049 (0)8941405019, daniel.reim@tum.de
    Scientific contact
    Prof. Dr. Daniel Reim, Klinikum rechts der Isar der Technischen Universität München Department of Surgery, 0049 (0)8941405019, daniel.reim@tum.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Jan 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Jan 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate whether the use of intraoperative, epifascial wound irrigation with polyhexanide (PHX) solution can reduce surgical site infections after laparotomy for visceral surgery compared to saline irrigation or no irrigation.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance the ethical principles of Good Clinical Practice (GCP). Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. The study was regularly monitored by the Sponsor and all investigators connected to the study were GCP trained.
    Background therapy
    		 Standard of care.
    Evidence for comparator
    		 No intraoperative wound irrigation.
    Actual start date of recruitment
    19 Sep 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 689
    Worldwide total number of subjects
    689
    EEA total number of subjects
    689
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    332
    From 65 to 84 years
    347
    85 years and over
    10

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted multicentric (10 study sites) in Germany. The recruitment took place between September 21, 2017 (first patient recruited) and January 3, 2022 (last patient completed).

    Pre-assignment
    Screening details
    		 All patients that underwent visceral surgery by laparotomy within the recruitment period were screened for the trial. The patients must be thoroughly informed about all aspects of the study. Only patients who meet all inclusion criteria and who do not have any exclusion criteria were included in the clinical study (screening).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Subject, Data analyst, Assessor
    Blinding implementation details
    The blinding procedure is restricted to participating patients, outcome assessors and the trial statistician. Blinding of the surgical team that performs the intervention is impossible because the control arm does not receive any wound irrigation. A member of the local study team, who will not take part in postoperative patient visits, performs randomization after confirmed closure of the abdominal fascia. A central online randomization tool of the MSZ (RANDOBASE) will effectuate randomization.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention I: PHX
    Arm description
    		 • Intervention 1: Irrigation of the subcutaneous tissue after closure of the abdominal fascia with 1000ml PHX solution (0.04%) Treatment Arm: To investigate whether the use of intraoperative, epifascial wound irrigation with polyhexanide (PHX) solution can reduce surgical site infections after laparotomy for visceral surgery compared to saline irrigation or no irrigation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    POLIHEXANIDE
    Investigational medicinal product code
    SUB09970MIG
    Other name
    CAS number 32289-58-0,
    Pharmaceutical forms
    Irrigation solution
    Routes of administration
    Other use
    Dosage and administration details
    1000 ml total

    Arm title
    		 Intervention 2: Saline
    Arm description
    		 • Intervention 2: Irrigation of the subcutaneous tissue after closure of the abdominal fascia with 1000ml saline solution (NaCl 0.9%)
    Arm type
    		 comperator

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 No Irrigation -control arm
    Arm description
    		 No Intervention - control arm (Standard of care)
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: This is an observer and patient blinded study.
    Number of subjects in period 1
    		Intervention I: PHX Intervention 2: Saline No Irrigation -control arm
    Started
    292
    295
    102
    Completed
    242
    238
    77
    Not completed
    50
    57
    25
         Adverse event, serious fatal
    2
    7
    2
         Consent withdrawn by subject
    4
    5
    2
         Adverse event, non-fatal
    30
    36
    16
         Not specified
    5
    -
    3
         Lost to follow-up
    9
    9
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Intervention I: PHX
    Reporting group description
    		 • Intervention 1: Irrigation of the subcutaneous tissue after closure of the abdominal fascia with 1000ml PHX solution (0.04%) Treatment Arm: To investigate whether the use of intraoperative, epifascial wound irrigation with polyhexanide (PHX) solution can reduce surgical site infections after laparotomy for visceral surgery compared to saline irrigation or no irrigation.

    Reporting group title
    Intervention 2: Saline
    Reporting group description
    		 • Intervention 2: Irrigation of the subcutaneous tissue after closure of the abdominal fascia with 1000ml saline solution (NaCl 0.9%)

    Reporting group title
    No Irrigation -control arm
    Reporting group description
    		 No Intervention - control arm (Standard of care)

    Reporting group values
    		 Intervention I: PHX Intervention 2: Saline No Irrigation -control arm Total
    Number of subjects
    		 292 295 102 689
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 138 137 57 332
        From 65-84 years
    		 151 153 43 347
        85 years and over
    		 3 5 2 10
    Gender categorical
    Units: Subjects
        Female
    		 126 124 37 287
        Male
    		 166 171 65 402
    ASA
    Units: Subjects
        ASA=1
    		 19 17 5 41
        ASA=2
    		 122 126 44 292
        ASA=3
    		 151 152 53 356
    BMI
    Body mass index
    Units: Subjects
        BMI < 18.5
    		 3 8 8 19
        18.5 <= BMI < 25
    		 145 125 39 309
        25 <= BMI < 30
    		 94 110 39 243
        30 <= BMI
    		 50 52 16 118
    Diabetes
    Diabetes as an ongoing comorbidity
    Units: Subjects
        yes
    		 54 59 21 134
        no
    		 238 236 81 555
    Smoker
    Units: Subjects
        no
    		 192 205 63 460
        yes, current
    		 45 47 18 110
        yes, previously
    		 55 43 21 119
    Alcohol
    Alcohol consume
    Units: Subjects
        no
    		 214 218 74 506
        yes, currently
    		 69 61 25 155
        yes, previously
    		 9 16 3 28
    Previous abdominal surgeries
    Units: Subjects
        yes
    		 175 200 65 440
        no
    		 117 95 37 249
    History of SSI
    Units: Subjects
        yes
    		 17 11 9 37
        no
    		 275 284 93 652
    History of radiotherapy
    Units: Subjects
        yes
    		 31 39 12 82
        no
    		 261 256 90 607
    History of chemotherapy
    Units: Subjects
        yes
    		 83 99 33 215
        no
    		 209 196 69 474
    Main surgery type
    Units: Subjects
        Colorectal
    		 56 52 21 129
        HBP
    		 174 177 60 411
        Upper-Gl
    		 54 55 18 127
        Other
    		 8 9 3 20
        Not specified
    		 0 2 0 2
    Level of contamination
    Units: Subjects
        Class I (clean)
    		 1 1 0 2
        Class II (clean-contaminated)
    		 271 272 94 637
        Class III (contaminated)
    		 18 22 8 48
        Class IV (dirty-infected)
    		 2 0 0 2
    Subject analysis sets

    Subject analysis set title
    Intention to treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT set contains all randomized patients with results attributed to the treatment group they were randomized to.

    Subject analysis sets values
    		 Intention to treat
    Number of subjects
    689
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    332
        From 65-84 years
    347
        85 years and over
    10
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    287
        Male
    402
    ASA
    Units: Subjects
        ASA=1
    41
        ASA=2
    292
        ASA=3
    356
    BMI
    Body mass index
    Units: Subjects
        BMI < 18.5
    19
        18.5 <= BMI < 25
    309
        25 <= BMI < 30
    243
        30 <= BMI
    118
    Diabetes
    Diabetes as an ongoing comorbidity
    Units: Subjects
        yes
    134
        no
    555
    Smoker
    Units: Subjects
        no
    460
        yes, current
    110
        yes, previously
    119
    Alcohol
    Alcohol consume
    Units: Subjects
        no
    506
        yes, currently
    155
        yes, previously
    28
    Previous abdominal surgeries
    Units: Subjects
        yes
    440
        no
    249
    History of SSI
    Units: Subjects
        yes
    37
        no
    652
    History of radiotherapy
    Units: Subjects
        yes
    82
        no
    607
    History of chemotherapy
    Units: Subjects
        yes
    215
        no
    474
    Main surgery type
    Units: Subjects
        Colorectal
    129
        HBP
    411
        Upper-Gl
    127
        Other
    20
        Not specified
    2
    Level of contamination
    Units: Subjects
        Class I (clean)
    2
        Class II (clean-contaminated)
    637
        Class III (contaminated)
    48
        Class IV (dirty-infected)
    2

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Intervention I: PHX
    Reporting group description
    		 • Intervention 1: Irrigation of the subcutaneous tissue after closure of the abdominal fascia with 1000ml PHX solution (0.04%) Treatment Arm: To investigate whether the use of intraoperative, epifascial wound irrigation with polyhexanide (PHX) solution can reduce surgical site infections after laparotomy for visceral surgery compared to saline irrigation or no irrigation.

    Reporting group title
    Intervention 2: Saline
    Reporting group description
    		 • Intervention 2: Irrigation of the subcutaneous tissue after closure of the abdominal fascia with 1000ml saline solution (NaCl 0.9%)

    Reporting group title
    No Irrigation -control arm
    Reporting group description
    		 No Intervention - control arm (Standard of care)

    Subject analysis set title
    Intention to treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT set contains all randomized patients with results attributed to the treatment group they were randomized to.

    Primary: SSI

    		 Close Top of page
    End point title
    		 SSI
    End point description
    Frequency of SSI within 30 days of surgery
    End point type
    Primary
    End point timeframe
    within 30 days of surgery
    End point values
    		 Intervention I: PHX Intervention 2: Saline No Irrigation -control arm Intention to treat
    Number of subjects analysed
    292
    295
    102
    689
    Units: patients
        yes
    31
    37
    13
    81
        no
    261
    258
    89
    608
    Statistical analysis title
    		 Competing risks I
    Statistical analysis description
    Subdistributional hazard model of Fine and Gray with SSI as main event, re-laparotomy and death as competing risks, treatment group, level of contamination, and BMI class as covariates.
    Comparison groups
    Intervention I: PHX v No Irrigation -control arm
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.544 [1]
    Method
    		 Fine and Gray subdistributional hazard
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.226
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.636
         upper limit
    		 2.364
    Notes
    [1] - Not statistically significant
    Statistical analysis title
    		 Competing risks II
    Statistical analysis description
    Subdistributional hazard model of Fine and Gray with SSI as main event, re-laparotomy and death as competing risks, treatment group, level of contamination, and BMI class as covariates.
    Comparison groups
    Intervention I: PHX v Intervention 2: Saline
    Number of subjects included in analysis
    587
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.471 [2]
    Method
    		 Fine and Gray subdistributional hazard
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.194
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.737
         upper limit
    		 1.937
    Notes
    [2] - Not statistically significant

    Secondary: Type of SSI

    		 Close Top of page
    End point title
    		 Type of SSI
    End point description
    End point type
    Secondary
    End point timeframe
    Within 30 days of surgery
    End point values
    		 Intervention I: PHX Intervention 2: Saline No Irrigation -control arm
    Number of subjects analysed
    292
    295
    102
    Units: patients
        No SSI
    254
    248
    85
        Superficial incisional SSI
    15
    22
    9
        Deep incisional SSI
    7
    6
    1
        Organ space SSI
    9
    9
    3
        Missing
    7
    10
    4
    Statistical analysis title
    		 Type of SSI I
    Statistical analysis description
    Difference in type of SSI between PHX and no irrigation
    Comparison groups
    Intervention I: PHX v No Irrigation -control arm
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.507
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Type of SSI II
    Statistical analysis description
    Difference in type of SSI between PHX and saline solution
    Comparison groups
    Intervention I: PHX v Intervention 2: Saline
    Number of subjects included in analysis
    587
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.699
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Re-laparotomy

    		 Close Top of page
    End point title
    		 Re-laparotomy
    End point description
    End point type
    Secondary
    End point timeframe
    Within 30 days of surgery
    End point values
    		 Intervention I: PHX Intervention 2: Saline No Irrigation -control arm
    Number of subjects analysed
    292
    295
    102
    Units: patients
        yes
    27
    31
    15
        no
    265
    264
    87
    Statistical analysis title
    		 Re-laparotomy I
    Statistical analysis description
    Differences in the frequency of re-laparotomy between PHX and no irrigation
    Comparison groups
    Intervention I: PHX v No Irrigation -control arm
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.124
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Re-laparotomy II
    Statistical analysis description
    Differences in the frequency of re-laparotomy between PHX and saline solution
    Comparison groups
    Intervention I: PHX v Intervention 2: Saline
    Number of subjects included in analysis
    587
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.609
    Method
    		 Chi-squared
    Confidence interval

    Secondary: 30-day mortality

    		 Close Top of page
    End point title
    		 30-day mortality
    End point description
    End point type
    Secondary
    End point timeframe
    within 30 days of surgery
    End point values
    		 Intervention I: PHX Intervention 2: Saline No Irrigation -control arm
    Number of subjects analysed
    292
    295
    102
    Units: patients
        died within 30 days of surgery
    2
    6
    2
        alive within 30 days of surgery
    290
    289
    100
    Statistical analysis title
    		 30 day mortality I
    Statistical analysis description
    Differences in 30-day mortality between PHX and no irrigation
    Comparison groups
    Intervention I: PHX v No Irrigation -control arm
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.276
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 30 day mortality II
    Statistical analysis description
    Differences in 30-day mortality between PHX and saline solution
    Comparison groups
    Intervention I: PHX v Intervention 2: Saline
    Number of subjects included in analysis
    587
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.286
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Any non-infectious wound complications

    		 Close Top of page
    End point title
    		 Any non-infectious wound complications
    End point description
    End point type
    Secondary
    End point timeframe
    within 30 days of surgery
    End point values
    		 Intervention I: PHX Intervention 2: Saline No Irrigation -control arm
    Number of subjects analysed
    292
    295
    102
    Units: patients
        yes
    53
    51
    21
        no
    232
    234
    77
        missig
    7
    10
    4
    Statistical analysis title
    		 Any non-infectious wound complications I
    Statistical analysis description
    Difference in the frequency of any non-infectious woulnd complications between PHX and no irrigation
    Comparison groups
    No Irrigation -control arm v Intervention I: PHX
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.54
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Any non-infectious wound complications II
    Statistical analysis description
    Difference in the frequency of any non-infectious woulnd complications between PHX and saline solution
    Comparison groups
    Intervention I: PHX v Intervention 2: Saline
    Number of subjects included in analysis
    587
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.828
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Duration of hospital stay

    		 Close Top of page
    End point title
    		 Duration of hospital stay
    End point description
    End point type
    Secondary
    End point timeframe
    entire study
    End point values
    		 Intervention I: PHX Intervention 2: Saline No Irrigation -control arm
    Number of subjects analysed
    292
    295
    102
    Units: day
        median (full range (min-max))
    14.5 (4 to 45)
    15 (5 to 41)
    13 (5 to 46)
    Statistical analysis title
    		 Duration of hospital stay I
    Statistical analysis description
    Difference in duration of hospital stay between PHX and no irrigation
    Comparison groups
    Intervention I: PHX v No Irrigation -control arm
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.563
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Duration of hospital stay II
    Statistical analysis description
    Difference in duration of hospital stay between PHX and saline solution
    Comparison groups
    Intervention I: PHX v Intervention 2: Saline
    Number of subjects included in analysis
    587
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.234
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Number of AEs per patient

    		 Close Top of page
    End point title
    		 Number of AEs per patient
    End point description
    End point type
    Secondary
    End point timeframe
    entire study
    End point values
    		 Intervention I: PHX Intervention 2: Saline No Irrigation -control arm
    Number of subjects analysed
    292
    295
    102
    Units: number
        median (full range (min-max))
    2 (0 to 18)
    2 (0 to 15)
    1 (1 to 20)
    Statistical analysis title
    		 Number of AEs per patient I
    Statistical analysis description
    Differences in the number of AEs per patient in PHX and no irrigation
    Comparison groups
    Intervention I: PHX v No Irrigation -control arm
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.823
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Number of AEs per patient II
    Statistical analysis description
    Differences in the number of AEs per patient in PHX and saline solution
    Comparison groups
    Intervention I: PHX v Intervention 2: Saline
    Number of subjects included in analysis
    587
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.128
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Number of SAEs per patient

    		 Close Top of page
    End point title
    		 Number of SAEs per patient
    End point description
    End point type
    Secondary
    End point timeframe
    entire study
    End point values
    		 Intervention I: PHX Intervention 2: Saline No Irrigation -control arm
    Number of subjects analysed
    292
    295
    102
    Units: number
        median (full range (min-max))
    0 (0 to 8)
    0 (0 to 5)
    0 (0 to 7)
    Statistical analysis title
    		 Number of SAEs per patient I
    Statistical analysis description
    Differences in the number of SAEs per patient between PHX and no irrigation
    Comparison groups
    Intervention I: PHX v No Irrigation -control arm
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.288
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Number of SAEs per patient II
    Statistical analysis description
    Differences in the number of SAEs per patient between PHX and saline solution
    Comparison groups
    Intervention I: PHX v Intervention 2: Saline
    Number of subjects included in analysis
    587
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.515
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    The obligation to document any AE in the study, starts with the randomization and ends with completion of the last study visit.
    Adverse event reporting additional description
    AE/SAEs are documented according to the standard grading on the AE/SAE reporting forms. Surgical site infections (primary endpoint) and all other local wound complications (secondary endpoint) will be documented as AE/SAE. In addition, their severity and the consequent treatment will be documented according to the Clavien Dindo classification.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Intervention I: PHX
    Reporting group description
    		 Patients treated with PHX irrigation

    Reporting group title
    Saline solution
    Reporting group description
    		 Irrigation with saline solution

    Reporting group title
    No irrigation
    Reporting group description
    		 -

    Serious adverse events
    		 Intervention I: PHX Saline solution No irrigation
    Total subjects affected by serious adverse events
         subjects affected / exposed
    95 / 291 (32.65%)
    104 / 295 (35.25%)
    63 / 103 (61.17%)
         number of deaths (all causes)
    17
    25
    8
         number of deaths resulting from adverse events
    17
    25
    8
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastric cancer
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to lung
         subjects affected / exposed
    0 / 291 (0.00%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Arterial haemorrhage
         subjects affected / exposed
    1 / 291 (0.34%)
    5 / 295 (1.69%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    3 / 291 (1.03%)
    3 / 295 (1.02%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Hypotension
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemia
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Lymphatic fistula
         subjects affected / exposed
    1 / 291 (0.34%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 291 (0.00%)
    2 / 295 (0.68%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Superior mesenteric artery syndrome
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hepatectomy
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Medical device battery replacement
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatectomy
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreaticojejunostomy
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Resuscitation
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tracheostomy
         subjects affected / exposed
    0 / 291 (0.00%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary cystectomy
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    0 / 291 (0.00%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    4 / 291 (1.37%)
    2 / 295 (0.68%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    1 / 291 (0.34%)
    2 / 295 (0.68%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    2 / 291 (0.69%)
    2 / 295 (0.68%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    Pain
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 291 (1.03%)
    3 / 295 (1.02%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asphyxia
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    3 / 291 (1.03%)
    5 / 295 (1.69%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pneumonia aspiration
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    4 / 291 (1.37%)
    2 / 295 (0.68%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    3 / 291 (1.03%)
    2 / 295 (0.68%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Thoracic haemorrhage
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    3 / 291 (1.03%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Biopsy pancreas
         subjects affected / exposed
    0 / 291 (0.00%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood electrolytes abnormal
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    1 / 291 (0.34%)
    3 / 295 (1.02%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inflammatory marker increased
         subjects affected / exposed
    4 / 291 (1.37%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcus test positive
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    White blood cell count increased
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    2 / 291 (0.69%)
    5 / 295 (1.69%)
    3 / 103 (2.91%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Anastomotic complication
         subjects affected / exposed
    7 / 291 (2.41%)
    9 / 295 (3.05%)
    5 / 103 (4.85%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
    Anastomotic leak
         subjects affected / exposed
    4 / 291 (1.37%)
    6 / 295 (2.03%)
    3 / 103 (2.91%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pancreatic leak
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anastomotic haemorrhage
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural bile leak
         subjects affected / exposed
    3 / 291 (1.03%)
    2 / 295 (0.68%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary anastomosis complication
         subjects affected / exposed
    0 / 291 (0.00%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brachial plexus injury
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal anastomotic leak
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal anastomosis complication
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative delirium
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative respiratory distress
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    3 / 291 (1.03%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suture related complication
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vulvovaginal injury
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    4 / 291 (1.37%)
    2 / 295 (0.68%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound haemorrhage
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound secretion
         subjects affected / exposed
    1 / 291 (0.34%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 291 (0.00%)
    2 / 295 (0.68%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Arrhythmia
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 291 (0.34%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 291 (0.34%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiovascular disorder
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 291 (0.34%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Monoparesis
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurological symptom
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vocal cord paresis
         subjects affected / exposed
    1 / 291 (0.34%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Splenic infarction
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intra-abdominal haemorrhage
         subjects affected / exposed
    1 / 291 (0.34%)
    1 / 295 (0.34%)
    3 / 103 (2.91%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Abdominal compartment syndrome
         subjects affected / exposed
    1 / 291 (0.34%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute abdomen
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 291 (0.34%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric perforation
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 291 (0.34%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal ischaemia
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal motility disorder
         subjects affected / exposed
    3 / 291 (1.03%)
    1 / 295 (0.34%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal necrosis
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    2 / 291 (0.69%)
    2 / 295 (0.68%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal dilatation
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal fistula
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    1 / 291 (0.34%)
    2 / 295 (0.68%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intra-abdominal fluid collection
         subjects affected / exposed
    2 / 291 (0.69%)
    2 / 295 (0.68%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 291 (0.34%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic fistula
         subjects affected / exposed
    3 / 291 (1.03%)
    6 / 295 (2.03%)
    2 / 103 (1.94%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritoneal haematoma
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 291 (0.00%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 291 (0.34%)
    1 / 295 (0.34%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary ascites
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 291 (0.00%)
    3 / 295 (1.02%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intra-abdominal haematoma
         subjects affected / exposed
    3 / 291 (1.03%)
    2 / 295 (0.68%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct necrosis
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary tract disorder
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biloma
         subjects affected / exposed
    2 / 291 (0.69%)
    3 / 295 (1.02%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    2 / 291 (0.69%)
    6 / 295 (2.03%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder fistula
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder rupture
         subjects affected / exposed
    2 / 291 (0.69%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Hepatic artery occlusion
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 291 (0.00%)
    2 / 295 (0.68%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Hepatic infarction
         subjects affected / exposed
    0 / 291 (0.00%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Portal vein occlusion
         subjects affected / exposed
    0 / 291 (0.00%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Portal vein stenosis
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    1 / 291 (0.34%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    3 / 291 (1.03%)
    0 / 295 (0.00%)
    2 / 103 (1.94%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Urethral disorder
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fistula
         subjects affected / exposed
    2 / 291 (0.69%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    2 / 291 (0.69%)
    2 / 295 (0.68%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal infection
         subjects affected / exposed
    0 / 291 (0.00%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Abscess
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder abscess
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    0 / 291 (0.00%)
    2 / 295 (0.68%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal gangrene
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Liver abscess
         subjects affected / exposed
    2 / 291 (0.69%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mesenteric abscess
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Perihepatic abscess
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 291 (0.00%)
    3 / 295 (1.02%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    6 / 291 (2.06%)
    3 / 295 (1.02%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    2 / 291 (0.69%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    3 / 291 (1.03%)
    2 / 295 (0.68%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 291 (0.34%)
    2 / 295 (0.68%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Superinfection
         subjects affected / exposed
    0 / 291 (0.00%)
    1 / 295 (0.34%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 291 (0.00%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    4 / 291 (1.37%)
    4 / 295 (1.36%)
    2 / 103 (1.94%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fluid retention
         subjects affected / exposed
    2 / 291 (0.69%)
    6 / 295 (2.03%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    2 / 291 (0.69%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 291 (0.00%)
    0 / 295 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 291 (0.00%)
    0 / 295 (0.00%)
    2 / 103 (1.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 3 diabetes mellitus
         subjects affected / exposed
    1 / 291 (0.34%)
    0 / 295 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Intervention I: PHX Saline solution No irrigation
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    179 / 291 (61.51%)
    198 / 295 (67.12%)
    40 / 103 (38.83%)
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    12 / 291 (4.12%)
    17 / 295 (5.76%)
    3 / 103 (2.91%)
         occurrences all number
    12
    18
    3
    Inflammatory marker increased
         subjects affected / exposed
    9 / 291 (3.09%)
    14 / 295 (4.75%)
    2 / 103 (1.94%)
         occurrences all number
    9
    16
    2
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    8 / 291 (2.75%)
    7 / 295 (2.37%)
    6 / 103 (5.83%)
         occurrences all number
    8
    7
    6
    Seroma
         subjects affected / exposed
    16 / 291 (5.50%)
    13 / 295 (4.41%)
    3 / 103 (2.91%)
         occurrences all number
    16
    13
    3
    Wound dehiscence
         subjects affected / exposed
    13 / 291 (4.47%)
    6 / 295 (2.03%)
    3 / 103 (2.91%)
         occurrences all number
    13
    6
    3
    General disorders and administration site conditions
    Impaired healing
         subjects affected / exposed
    21 / 291 (7.22%)
    15 / 295 (5.08%)
    3 / 103 (2.91%)
         occurrences all number
    21
    16
    3
    Pyrexia
         subjects affected / exposed
    12 / 291 (4.12%)
    15 / 295 (5.08%)
    3 / 103 (2.91%)
         occurrences all number
    12
    16
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    30 / 291 (10.31%)
    29 / 295 (9.83%)
    5 / 103 (4.85%)
         occurrences all number
    30
    29
    5
    Vomiting
         subjects affected / exposed
    20 / 291 (6.87%)
    24 / 295 (8.14%)
    6 / 103 (5.83%)
         occurrences all number
    20
    25
    6
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    9 / 291 (3.09%)
    19 / 295 (6.44%)
    0 / 103 (0.00%)
         occurrences all number
    9
    21
    0
    Wound infection
         subjects affected / exposed
    12 / 291 (4.12%)
    11 / 295 (3.73%)
    7 / 103 (6.80%)
         occurrences all number
    12
    12
    7
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    19 / 291 (6.53%)
    30 / 295 (10.17%)
    8 / 103 (7.77%)
         occurrences all number
    19
    33
    8

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 May 2019
    Addition of two further trial sites
    08 Mar 2021
    Major changes: - Extension of study duration - Changes in statistical analysis plan because of an unexpected high number of drop-outs due to relaparotomy - to maintain statistical power, the sample size had to be increased

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 02 11:48:43 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA