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    Clinical Trial Results:
    Randomized clinical trial to evaluate the dose and administration time of indocyanine green in near-infrared fluorescent cholangiography during laparoscopic cholecystectomy.

    Summary
    EudraCT number
    		 2022-000904-36
    Trial protocol
    		 ES  
    Global end of trial date
    14 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jun 2024
    First version publication date
    09 Jun 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IBS-DOTIG-ECM-2202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05419947
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Institute for Biomedical Research of Salamanca (IBSAL)
    Sponsor organisation address
    P.º de San Vicente, 182, Salamanca, Spain, 37007
    Public contact
    Área de Ensayos Clínicos, UICEC IBSAL, 0034 923291200 ext 55114, uicec.gestion@ibsal.es
    Scientific contact
    Área de Ensayos Clínicos, UICEC IBSAL, 696022264 923291200 ext 55114, uicec.gestion@ibsal.es
    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
    15 Apr 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study is to analyze whether there are differences between different types of doses and administration intervals of indocyanine green to obtain quality fluorescent cholangiography during laparoscopic cholecystectomy. In addition, the factors that influence the results of the technique will be sought.
    Protection of trial subjects
    The project had the prior favorable report from the Ethics Committee for Drug Research of the Health Area of Salamanca. The project development was carried out in accordance with current ethical standards, the Declaration of Helsinki, and data protection legislation (Law 3/2018 and European Regulation 2016/679). Confidentiality and security of information were ensured by deleting non-anonymized data and restricting access in case of patent.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    01 Jul 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 200
    Worldwide total number of subjects
    200
    EEA total number of subjects
    200
    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)
    103
    From 65 to 84 years
    88
    85 years and over
    9

    Subject disposition

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    Recruitment
    Recruitment details
    		 The annual rate of LC in the two hospitals in the study is over 300 surgeries per year. In order to recruit 200 in both centres, a review waiting list will be conducted. Patients who meet the inclusion criteria will be given the necessary information and, after signing the informed consent form, will be included in the trial.

    Pre-assignment
    Screening details
    		 Patients scheduled for laparoscopic cholecystectomy who meet all inclusion criteria and none of the exclusion criteria

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Dosage and administration details: 2,5 mg >3 hours prior to surgery
    Arm type
    		 Experimental

    Investigational medicinal product name
    Indocyanine green
    Investigational medicinal product code
    3599-32-4
    Other name
    IC-Green
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    2,5 mg >3 hours prior to surgery

    Arm title
    		 Group 2
    Arm description
    		 Dosage and administration details: 2,5 mg 15-30 minutes prior to surgery
    Arm type
    		 Experimental

    Investigational medicinal product name
    Indocyanine green
    Investigational medicinal product code
    3599-32-4
    Other name
    IC-Green
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    2,5 mg 15-30 minutes prior to surgery

    Arm title
    		 Group 3
    Arm description
    		 Dosage and administration details: 0,05 mg/kg >3 hours prior to surgery
    Arm type
    		 Experimental

    Investigational medicinal product name
    Indocyanine green
    Investigational medicinal product code
    3599-32-4
    Other name
    IC-Green
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    0,05 mg/kg >3 hours prior to surgery

    Arm title
    		 Group 4
    Arm description
    		 Dosage and administration details: 0,05 mg/kg 15-30 minutes prior to surgery
    Arm type
    		 Experimental

    Investigational medicinal product name
    Indocyanine green
    Investigational medicinal product code
    3599-32-4
    Other name
    IC-Green
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    0,05 mg/kg 15-30 minutes prior to surgery

    Number of subjects in period 1
    		Group 1 Group 2 Group 3 Group 4
    Started
    49
    45
    44
    62
    Completed
    47
    45
    44
    60
    Not completed
    2
    0
    0
    2
         Physician decision
    1
    -
    -
    1
         Consent withdrawn by subject
    1
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Reporting group values
    		 Overall Total
    Number of subjects
    		 200 200
    Age categorical
    Patients scheduled for laparoscopic cholecystectomy who meet all inclusion criteria and none of the exclusion criteria.
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 103 103
        From 65-84 years
    		 88 88
        85 years and over
    		 9 9
    Gender categorical
    Patients scheduled for laparoscopic cholecystectomy who meet all inclusion criteria and none of the exclusion criteria.
    Units: Subjects
        Female
    		 121 121
        Male
    		 79 79

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Dosage and administration details: 2,5 mg >3 hours prior to surgery

    Reporting group title
    Group 2
    Reporting group description
    		 Dosage and administration details: 2,5 mg 15-30 minutes prior to surgery

    Reporting group title
    Group 3
    Reporting group description
    		 Dosage and administration details: 0,05 mg/kg >3 hours prior to surgery

    Reporting group title
    Group 4
    Reporting group description
    		 Dosage and administration details: 0,05 mg/kg 15-30 minutes prior to surgery

    Primary: Identification of biliary structures prior to dissection of the hepatocystic triangle

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    End point title
    		 Identification of biliary structures prior to dissection of the hepatocystic triangle [1]
    End point description
    Identification of biliary structures prior to dissection of the hepatocystic triangle. Number of Subject with structures Cat 1. Identification of the cystic duct prior to dissection Cat 2. Identification of the common bile duct prior to dissection Cat 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Cat 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Cat 5. Identification of the common hepatic duct prior to dissection Cat 6. Identification of biliary anatomical variables prior to dissection
    End point type
    Primary
    End point timeframe
    At the time of the surgical procedure
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The results are purely descriptive and do not warrant additional statistical analysis beyond that.
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    47
    45
    44
    60
    Units: Subject
    number (not applicable)
        Cat 1
    26
    20
    26
    29
        Cat 2
    32
    25
    28
    36
        Cat 3
    15
    12
    18
    19
        Cat 4
    23
    19
    25
    19
        Cat 5
    16
    16
    16
    25
        Cat 6
    2
    1
    1
    0
    No statistical analyses for this end point

    Primary: Identification of biliary structures after dissection of the hepatocystic triangle

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    End point title
    		 Identification of biliary structures after dissection of the hepatocystic triangle [2]
    End point description
    Identification of biliary structures after dissection of the hepatocystic triangle. Cat 1.Identification of the cystic duct after to dissection Cat 2. Identification of the common bile duct after to dissection Cat 3. Identification of the junction of the cystic duct with the common bile duct after to dissection Cat 4. Identification of the union of the cystic duct with the gallbladder after to dissection Cat 5. Identification of the common hepatic duct after to dissection Cat 6. Identification of biliary anatomical variables after to dissection
    End point type
    Primary
    End point timeframe
    At the time of the surgical procedure
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The results are purely descriptive and do not warrant additional statistical analysis beyond that.
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    47
    45
    44
    60
    Units: Subject
    number (not applicable)
        Cat 1
    40
    38
    36
    45
        Cat 2
    42
    33
    35
    48
        Cat 3
    37
    30
    29
    40
        Cat 4
    41
    35
    36
    40
        Cat 5
    24
    26
    25
    36
        Cat 6
    6
    5
    5
    3
    No statistical analyses for this end point

    Primary: Degree of identification of biliary structures prior to dissection of the hepatocystic triangle

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    End point title
    		 Degree of identification of biliary structures prior to dissection of the hepatocystic triangle [3]
    End point description
    Degree of identification of biliary structures prior to dissection of the hepatocystic triangle. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent
    End point type
    Primary
    End point timeframe
    At the time of the surgical procedure
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The results are purely descriptive and do not warrant additional statistical analysis beyond that.
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    47
    45
    44
    60
    Units: Subject
    number (not applicable)
        1=little
    13
    20
    12
    26
        2=sufficient
    11
    7
    4
    11
        3=quite a bit
    6
    5
    9
    3
        4=good
    12
    7
    10
    14
        5=excellent
    7
    6
    9
    8
    No statistical analyses for this end point

    Primary: Degree of identification of biliary structures after dissection of the hepatocystic triangle

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    End point title
    		 Degree of identification of biliary structures after dissection of the hepatocystic triangle [4]
    End point description
    Degree of identification of biliary structures after dissection of the hepatocystic triangle. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent
    End point type
    Primary
    End point timeframe
    At the time of the surgical procedure
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The results are purely descriptive and do not warrant additional statistical analysis beyond that.
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    47
    45
    44
    60
    Units: Subject
    number (not applicable)
        1=little
    6
    6
    5
    13
        2=sufficient
    6
    12
    6
    10
        3=quite a bit
    8
    4
    5
    5
        4=good
    13
    6
    15
    16
        5=excellent
    16
    17
    13
    18
    No statistical analyses for this end point

    Primary: Extent to which fluorescence cholangiography was perceived as useful for surgery

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    End point title
    		 Extent to which fluorescence cholangiography was perceived as useful for surgery [5]
    End point description
    Extent to which fluorescence cholangiography was perceived as useful for surgery The following scale will be used: 0=not useful, 1=moderately useful, 2=very useful
    End point type
    Primary
    End point timeframe
    At the time of the surgical procedure
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The results are purely descriptive and do not warrant additional statistical analysis beyond that.
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    47
    45
    44
    60
    Units: Useful scale
        0=not useful
    4
    9
    3
    13
        1=moderately useful
    23
    24
    19
    24
        2=very useful
    22
    12
    22
    25
    No statistical analyses for this end point

    Primary: Extent to which liver fundus fluorescence (contrast between liver and ducts) was perceived as disturbing

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    End point title
    		 Extent to which liver fundus fluorescence (contrast between liver and ducts) was perceived as disturbing [6]
    End point description
    Extent to which liver fundus fluorescence (contrast between liver and ducts) was perceived as disturbing. The following scale will be used: 0=no disturbance, 1=slightly disturbed, 2=disturbed visualization, but cystic-bile duct junction was clearly visible before dissection, 3=disturbed visualization and cystic-bile duct junction was only visible after dissection. dissection and 4= very disturbed: it was impossible to correctly visualize the biliary structures
    End point type
    Primary
    End point timeframe
    At the time of the surgical procedure
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The results are purely descriptive and do not warrant additional statistical analysis beyond that.
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    47
    45
    44
    60
    Units: Disturbing scale
        Cat 0
    27
    12
    26
    7
        Cat 1
    17
    17
    13
    21
        Cat 2
    4
    4
    5
    16
        Cat 3
    1
    9
    0
    9
        Cat 4
    0
    3
    0
    9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The adverse event collection period in this study extends from the time of surgery until one month post-surgery
    Adverse event reporting additional description
    In the DOTIG study, a total of 200 patients were enrolled. Throughout the study, 109 AEs were collected, of which 14 (12.8%) were reported as serious adverse events (SAEs). None of these SAEs showed a causal relationship with the study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Valid patients
    Reporting group description
    		 Patients scheduled for laparoscopic cholecystectomy who meet all inclusion criteria and none of the exclusion criteria.

    Serious adverse events
    		 Valid patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 196 (4.59%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma
    Additional description: It refers to a type of cancer that originates in the glandular cells lining the internal and external surfaces of the body
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
    Additional description: Medical condition characterized by disorganized electrical impulses in the atria (the upper chambers of the heart), leading to an irregular and often rapid heartbeat. Atrial fibrillation can increase the risk of blood clots, strokes, and other heart-
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Heart Failure
    Additional description: A chronic condition characterized by the heart's inability to pump enough blood to meet the body's needs.
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Hypersensitivity
    Additional description: Exaggerated immune response to a specific substance, known as an allergen
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Acute Pancreatitis
    Additional description: It refers to the sudden inflammation of the pancreas, which can range from mild and self-limiting to severe and potentially life-threatening.
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
    Additional description: Abdominal pain refers to discomfort or pain felt in the area between the chest and the pelvis.
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileus paralytic
    Additional description: Condition characterized by the temporary paralysis of the muscles of the intestine, which prevents the movement of food, fluid, and gas through the digestive tract
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholecystitis
    Additional description: An inflammatory condition of the gallbladder, typically caused by the presence of gallstones blocking the cystic duct
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholangitis
    Additional description: An inflammation of the bile ducts, which are the tubes that carry bile from the liver to the gallbladder and intestines
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
    Additional description: A condition in which the respiratory system fails to adequately oxygenate the blood and/or remove carbon dioxide from the body.
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Abscess
    Additional description: Localized collection of pus that can occur anywhere in the body
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intraabdominal fluid collection
    Additional description: the accumulation of fluid within the abdominal cavity. This can occur due to various reasons such as trauma, infection, inflammation, or surgery.
         subjects affected / exposed
    2 / 196 (1.02%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Valid patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 196 (33.67%)
    Vascular disorders
    Ecchymosis
    Additional description: Ecchymosis in the surgical wound.
         subjects affected / exposed
    2 / 196 (1.02%)
         occurrences all number
    2
    Phlebitis
         subjects affected / exposed
    3 / 196 (1.53%)
         occurrences all number
    3
    Haematoma
         subjects affected / exposed
    3 / 196 (1.53%)
         occurrences all number
    3
    Hypotension
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    2 / 196 (1.02%)
         occurrences all number
    2
    Fever
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    4 / 196 (2.04%)
         occurrences all number
    4
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    2 / 196 (1.02%)
         occurrences all number
    2
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    2 / 196 (1.02%)
         occurrences all number
    2
    Psychiatric disorders
    Anxiety disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Nervousness
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Dehiscence
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Accident
    Additional description: Trauma caused by car accident
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Thermal burn
         subjects affected / exposed
    2 / 196 (1.02%)
         occurrences all number
    2
    Wound secretion
         subjects affected / exposed
    2 / 196 (1.02%)
         occurrences all number
    2
    Cardiac disorders
    Sinus arrhythmia
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Sinus bradycardia
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Tachycardia
         subjects affected / exposed
    2 / 196 (1.02%)
         occurrences all number
    2
    Nervous system disorders
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 196 (2.04%)
         occurrences all number
    4
    Disorientation
    Additional description: Time and spatial disorientation
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Paraesthesia
    Additional description: Leg paraesthesia
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Somnolence
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Coagulopathy
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 196 (2.55%)
         occurrences all number
    5
    Abdominal pain
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    2 / 196 (1.02%)
         occurrences all number
    3
    Melaena
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    14 / 196 (7.14%)
         occurrences all number
    14
    Hepatobiliary disorders
    Acute cholecystitis necrotic
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Gallbladder rupture
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Cholelithiasis
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Subcutaneous emphysema
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Rash
    Additional description: Exanthema in laparoscopic trocars
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Omphalitis
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Urinary retention
    Additional description: Acute urinary retention
         subjects affected / exposed
    2 / 196 (1.02%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Sacral pain
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    3
    Infections and infestations
    Abscess
         subjects affected / exposed
    2 / 196 (1.02%)
         occurrences all number
    2
    Abscess intestinal
         subjects affected / exposed
    2 / 196 (1.02%)
         occurrences all number
    2
    Conjunctivitis
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    COVID-19
         subjects affected / exposed
    3 / 196 (1.53%)
         occurrences all number
    3
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Infection
    Additional description: Surgery site infection
         subjects affected / exposed
    3 / 196 (1.53%)
         occurrences all number
    3
    Fungal infection
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Cachexia
    Additional description: Post-surgery nausea and vomiting
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 196 (0.51%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36868593
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