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    Clinical Trial Results:
    Are phrophylactic antibiotics necessary before laparoscopic living kidney donation? A double blind, randomised, controlled trial.

    Summary
    EudraCT number
    2012-000942-36
    Trial protocol
    GB  
    Global end of trial date
    12 Jul 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    25 Aug 2019
    First version publication date
    25 Aug 2019
    Other versions
    Summary report(s)
    FINAL REPORT

    Trial information

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    Trial identification
    Sponsor protocol code
    POWAR
    Additional study identifiers
    ISRCTN number
    ISRCTN71141360
    US NCT number
    NCT02089568
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Guy's and St Thomas' NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE19RT
    Public contact
    Nizam Mamode, Guy's & St Thomas' NHS Foundation Trust, 0044 02071888476, nizam.mamode@gstt.nhs.uk
    Scientific contact
    Nizam Mamode, Guy's & St Thomas' NHS Foundation Trust, 0044 02071888476, nizam.mamode@gstt.nhs.uk
    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
    12 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal question is whether a single dose of antibiotic prior to donating a kidney reduces infections within 30 days of surgery.
    Protection of trial subjects
    The IMP or Placebo will be administered intravenously at induction of anaesthesia for donor nephrectomy.
    Background therapy
    n/a
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Oct 2012
    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
    United Kingdom: 295
    Worldwide total number of subjects
    295
    EEA total number of subjects
    295
    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)
    295
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were recruited from 5 clinical sites in the UK between 2012 and 2016.

    Pre-assignment
    Screening details
    Inclusion Criteria Male and Female patients (over 18 years) undergoing hand-assisted laparoscopic donor nephrectomy Patients who have given written informed consent to participate Patients whose first language is not English will be included; they comprise a significant part of our patient population and we will use translation services as is ou

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    Matching intravenous solution will be provided for placebo.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    ACTIVE - co-amoxiclav,
    Arm description
    Active IMP will be given at induction of anaesthesia prior to laparoscopic donor nephrectomy.
    Arm type
    Experimental

    Investigational medicinal product name
    Co-Amoxiclav
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.2g gi ven intravenously a induction of anaesthesia

    Arm title
    PLACEBO
    Arm description
    Placebo administered as Intravenous injection on induction of anaesthesia.
    Arm type
    Placebo

    Investigational medicinal product name
    0.9% Normal Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as single intravenous injection at induction of anaesthesia

    Number of subjects in period 1
    ACTIVE - co-amoxiclav, PLACEBO
    Started
    149
    146
    Completed
    144
    141
    Not completed
    5
    5
         Physician decision
    -
    1
         Required antibiotics
    -
    2
         Surgery cancelled
    3
    2
         Received antibiotics inadvertantly
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ACTIVE - co-amoxiclav,
    Reporting group description
    Active IMP will be given at induction of anaesthesia prior to laparoscopic donor nephrectomy.

    Reporting group title
    PLACEBO
    Reporting group description
    Placebo administered as Intravenous injection on induction of anaesthesia.

    Reporting group values
    ACTIVE - co-amoxiclav, PLACEBO Total
    Number of subjects
    149 146 295
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    149 146 295
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    66 58 124
        Male
    83 88 171

    End points

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    End points reporting groups
    Reporting group title
    ACTIVE - co-amoxiclav,
    Reporting group description
    Active IMP will be given at induction of anaesthesia prior to laparoscopic donor nephrectomy.

    Reporting group title
    PLACEBO
    Reporting group description
    Placebo administered as Intravenous injection on induction of anaesthesia.

    Primary: Clinical Endpoint

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    End point title
    Clinical Endpoint [1]
    End point description
    The primary outcome measure will be a composite endpoint of any infection; this will include surgical site infections as well as urinary tract, respiratory and any other infections, within 30 days of surgery. Specifically, the primary endpoint will be defined as the occurrence of any of the following: Purulent drainage from the incision site, confirmed on microbiological testing (significant bacterial growth and pus cells present) Positive culture of any fluid aspirated from the surgical site At least two of the following at the incision site: fever, pain, swelling, redness, heat and either the wound is opened by the surgeon or the clinician diagnoses an infection Dehiscence of the surgical wound Evidence of deep infection at reoperation or radiologically Symptomatic urinary tract infection (dysuria, fever) with culture positive MSU including pyuria Symptomatic respiratory tract infection (fever, productive cough, dsyp
    End point type
    Primary
    End point timeframe
    Within 30 days of surgery.
    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: Please see attached report for results.
    End point values
    ACTIVE - co-amoxiclav, PLACEBO
    Number of subjects analysed
    144
    141
    Units: whole
    144
    141
    Attachments
    RESULTS
    No statistical analyses for this end point

    Secondary: Secondary clinical endpoint

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    End point title
    Secondary clinical endpoint
    End point description
    Secondary endpoints will include ultrasonic evidence of wound healing, length of hospital stay, readmission rates, antibiotic associated side effects (including diarrhoea and allergic reactions), return to work and normal activities, quality of life and relative costs.
    End point type
    Secondary
    End point timeframe
    within 30 days post surgery
    End point values
    ACTIVE - co-amoxiclav, PLACEBO
    Number of subjects analysed
    144
    141
    Units: whole
    144
    141
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Until 30 days post surgery
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    ACTIVE GROUP
    Reporting group description
    -

    Reporting group title
    PLACEBO GROUP
    Reporting group description
    -

    Serious adverse events
    ACTIVE GROUP PLACEBO GROUP
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 150 (14.00%)
    22 / 149 (14.77%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Fluid retention
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Bowel resection
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 150 (0.00%)
    2 / 149 (1.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Shortness of breath
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    9 / 150 (6.00%)
    4 / 149 (2.68%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound haematoma
         subjects affected / exposed
    2 / 150 (1.33%)
    2 / 149 (1.34%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 150 (0.00%)
    2 / 149 (1.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 150 (0.67%)
    2 / 149 (1.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 150 (0.67%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    2 / 150 (1.33%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 150 (0.67%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected haematoma
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fat necrosis
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Morganella infection
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia and rash
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal infection
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Admission to hospital for Abdominal subcutaneous collection
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    ACTIVE GROUP PLACEBO GROUP
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    72 / 150 (48.00%)
    82 / 149 (55.03%)
    Vascular disorders
    Hypotensive
         subjects affected / exposed
    3 / 150 (2.00%)
    5 / 149 (3.36%)
         occurrences all number
    3
    5
    Haematoma
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Vasovagal
         subjects affected / exposed
    0 / 150 (0.00%)
    2 / 149 (1.34%)
         occurrences all number
    0
    2
    Loss of conciousness: Impression vasovagal on background of hypovolaemia and opiate excess
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    epigastric artery bleeding and rectus sheath haematoma requiring coiling
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Hb drop overnight
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Raised blood pressure
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Post operative ileus
         subjects affected / exposed
    0 / 150 (0.00%)
    3 / 149 (2.01%)
         occurrences all number
    0
    3
    soft palate laceration repair
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Post operative pain
         subjects affected / exposed
    2 / 150 (1.33%)
    1 / 149 (0.67%)
         occurrences all number
    2
    1
    post op surgical emphysema
         subjects affected / exposed
    0 / 150 (0.00%)
    2 / 149 (1.34%)
         occurrences all number
    0
    2
    Recent self drainage of small subcutaneous pus collection
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Midline wound slightly open
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Ongoing pain and post- operative ileus
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Wound seroma- drained
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    2
    Surgical evacuation of haematoma
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Surgical wound feeling 'tight' after prolonged movement
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    SPLENIC INJURY INTRAOP
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Middle port site (not the lateral one) superficailly broken down
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Surgical emphysema
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Port site redressed as reported bleeding
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Contrast CT for increased pain in surgical site
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    USS of surgical site
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Aspiration of anechoic simple collection just superior to the Pfannenstiel incision, separate to bla
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Red patches noted on patient's chest thta seemed like dilated blood vessels (shortly after having cy
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Allergic reaction across wound
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Allergy to wound dressing
         subjects affected / exposed
    2 / 150 (1.33%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    Anaphylaxis to contrast media
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Itchiness
         subjects affected / exposed
    3 / 150 (2.00%)
    3 / 149 (2.01%)
         occurrences all number
    3
    3
    Feeling unwell
         subjects affected / exposed
    2 / 150 (1.33%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    Toothache
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Patient appears 'puffy' and reports feeling bloated
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Increased temperature
         subjects affected / exposed
    1 / 150 (0.67%)
    2 / 149 (1.34%)
         occurrences all number
    1
    2
    Tiredness
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    WEAK VOICE
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Low in mood
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Testicular pain
         subjects affected / exposed
    1 / 150 (0.67%)
    4 / 149 (2.68%)
         occurrences all number
    1
    4
    Unusual PV bleeding
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Swelling of sotum and penis and discolourations
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Mild swelling in the left testicle with no bruising
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Itchiness around the foreskin
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    PERI UVULA ERYTHEMA
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Wound related pain on movement
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Small superficial collections
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    handport haematoma requiring evacuation
         subjects affected / exposed
    2 / 150 (1.33%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    Wound pain
         subjects affected / exposed
    4 / 150 (2.67%)
    2 / 149 (1.34%)
         occurrences all number
    4
    2
    Shoulder pain
         subjects affected / exposed
    1 / 150 (0.67%)
    2 / 149 (1.34%)
         occurrences all number
    2
    2
    On-going left flank discomfort +occassional sharp pains- eg on walking
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Pain in the right para vertebral region, , around the apex of the scapula, the pain increase with mo
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Mild surgical emphysema left abdomen
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Intermittent pain in right calf
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Superficial haematoma 1cm bigger than previously
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    'Slow healing at the left lateral working port
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Pain near left lateral port site
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    post operative haematoma
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Superficial collection below her vertical umbilical wound- managed conservatively (8x5x3 cms on 13/1
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    0 / 150 (0.00%)
    2 / 149 (1.34%)
         occurrences all number
    0
    2
    WOUND SEROMA
         subjects affected / exposed
    2 / 150 (1.33%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    Midline incisiona paraincisional swelling
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Intermittent pain in remaining kidney- new onset
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    'Stingy' and 'sore' surgical site
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Ultrasound of surgical site- haemoatoma
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Small monocryl knot
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Right lateral aspect anterior abdominal wound swelling- small fluid collection 15x12mm on USS
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Investigations
    low sodium
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Ultrasound Doppler right leg (NAD)
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    ECGs show the T wave in lead III has inverted and is now upright
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Chest Pain
         subjects affected / exposed
    2 / 150 (1.33%)
    1 / 149 (0.67%)
         occurrences all number
    2
    1
    Tachycardia
         subjects affected / exposed
    3 / 150 (2.00%)
    0 / 149 (0.00%)
         occurrences all number
    3
    0
    Palpitations associated anterior T wave inversion on serial ECGs
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Slight neutrophilia
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Chest infection
         subjects affected / exposed
    1 / 150 (0.67%)
    1 / 149 (0.67%)
         occurrences all number
    1
    1
    hypoxia due to basal atelectasis. CTPA -ve
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    postoperative hypoxia negative CTPA
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Pleuritic CP with left shoulder pain
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Pneumoperitoneum on right, effusion left base
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    cough - productive small volume green phlegm
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Reduced air entry both bases with low grade pyrexia
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Post op atelectasis
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Shortness fo breath, chest auscultation- quiet bases
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Discomfort and phlegm in centre of chest when breathing in - not when eating
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Sats dropped but improved on exercise
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Reduced air entry at bases
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Faint episode
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    2
    Dizziness
         subjects affected / exposed
    1 / 150 (0.67%)
    2 / 149 (1.34%)
         occurrences all number
    1
    2
    Insomnia
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Depression
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Panic attack
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    'Lightheadedness'
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Hallucinations
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Pins and needles over lateral aspect of left thigh- occasional episodes and improving
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Increased floaters in vision
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Red itchy eye on right side which has been washed out this morning: mild exposure keratopathy
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Cornial abrasion to right eye sustained during operation.
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal bloating
         subjects affected / exposed
    8 / 150 (5.33%)
    7 / 149 (4.70%)
         occurrences all number
    9
    7
    Pain in Abdominal area
         subjects affected / exposed
    6 / 150 (4.00%)
    16 / 149 (10.74%)
         occurrences all number
    6
    20
    Chlorhexidine allergy on abdomen
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    0
    complex incisional subcutaneous haematoma
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    anechoic collection on abdominal ultrasound
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    Consitpation
         subjects affected / exposed
    8 / 150 (5.33%)
    7 / 149 (4.70%)
         occurrences all number
    11
    8
    Nausea and/or vomiting
         subjects affected / exposed
    13 / 150 (8.67%)
    18 / 149 (12.08%)
         occurrences all number
    13
    19
    Diarrhoea
         subjects affected / exposed
    2 / 150 (1.33%)
    2 / 149 (1.34%)
         occurrences all number
    2
    2
    Loss of appetite
         subjects affected / exposed
    0 / 150 (0.00%)
    2 / 149 (1.34%)
         occurrences all number
    0
    2
    Intermittent "burning sensation" abdomen
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Capsular splenic tear
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Upset stomach
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    CT abdo pelvis today- small collection left side with no other significant findings
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Ileus
         subjects affected / exposed
    1 / 150 (0.67%)
    2 / 149 (1.34%)
         occurrences all number
    1
    2
    PCA induced nausea and vomiting
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    slightly elevated blood sugar
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    small bowel obstruction
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Fluid collection
         subjects affected / exposed
    9 / 150 (6.00%)
    1 / 149 (0.67%)
         occurrences all number
    9
    1
    splenic tear.
         subjects affected / exposed
    0 / 150 (0.00%)
    2 / 149 (1.34%)
         occurrences all number
    0
    2
    Irregular bowels
         subjects affected / exposed
    1 / 150 (0.67%)
    1 / 149 (0.67%)
         occurrences all number
    1
    1
    Loose Stools
         subjects affected / exposed
    2 / 150 (1.33%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Does not have full bowel sensation
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    RENAL COLIC
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Frothy urine
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Sensation of being unable to empty his bladder
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Elevated creatinine
         subjects affected / exposed
    0 / 150 (0.00%)
    3 / 149 (2.01%)
         occurrences all number
    0
    3
    Raised CRP
         subjects affected / exposed
    2 / 150 (1.33%)
    1 / 149 (0.67%)
         occurrences all number
    2
    1
    Urinary retention requiring re urinary catheterisation
         subjects affected / exposed
    1 / 150 (0.67%)
    1 / 149 (0.67%)
         occurrences all number
    1
    1
    VISIBLE HAEMATURIA
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Urine was slow to start with post operation, now normal flow
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Urinary urgency
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Low urine output
         subjects affected / exposed
    2 / 150 (1.33%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    No difficultly in PU but does not have normal full sensation and has to strain slightly
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    Creatinine 162
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Suspected urine infection. Given 5/7of Co-Amoxiclav antibiotics
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Urine dip- leukocytes +++ and rising CRP.
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Mild LFT raise
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Hand oedema
         subjects affected / exposed
    1 / 150 (0.67%)
    1 / 149 (0.67%)
         occurrences all number
    1
    1
    Swelling of upper lip
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Skin RIF tender to palpation. Some stretching on left flank
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Bulge L flank
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    SKIN IRRITATION FROM DRESSING
         subjects affected / exposed
    1 / 150 (0.67%)
    1 / 149 (0.67%)
         occurrences all number
    1
    1
    rash
         subjects affected / exposed
    1 / 150 (0.67%)
    1 / 149 (0.67%)
         occurrences all number
    1
    1
    Rash over body and flexural area rashes. Itchy and blanching.
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Itchy rash to upper thigh. GP prescribed Daktacort cream ?fungal infection
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    'Lump' around surgical scar
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    swollen testicle and groin pain
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Muscular neck pain
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Sharp pain right hip
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Some minor aches left of wound, under rib cage +ocassionally tip of left shoulder
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Xray of right shoulder- calcification of the soft tissues around the shoulder joint likely to be chr
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    intermittent left flank pain and left testicular swelling
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Discomfort in groin
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Impreson Musculoskeletal chest pain
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Backache
         subjects affected / exposed
    2 / 150 (1.33%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    Mildly antalgic gait
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Pain in right shoulder charcterised by reduced range of movement
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Infections and infestations
    Wound infection with/without ooze
         subjects affected / exposed
    10 / 150 (6.67%)
    15 / 149 (10.07%)
         occurrences all number
    11
    15
    Generally unwell
    Additional description: Commenced antibiotics
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Incision and evacuation of subcutaneous abscess
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    CRP elevated
         subjects affected / exposed
    2 / 150 (1.33%)
    2 / 149 (1.34%)
         occurrences all number
    2
    2
    Pyrexia
         subjects affected / exposed
    12 / 150 (8.00%)
    7 / 149 (4.70%)
         occurrences all number
    12
    7
    Ulcer on palate
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Sore throat
         subjects affected / exposed
    1 / 150 (0.67%)
    1 / 149 (0.67%)
         occurrences all number
    1
    1
    Pneumonia
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Cold (viral)
         subjects affected / exposed
    1 / 150 (0.67%)
    1 / 149 (0.67%)
         occurrences all number
    1
    1
    Feels hot and sweaty. One episode of ?rigors
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Bladder irritation
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    UTI
         subjects affected / exposed
    1 / 150 (0.67%)
    2 / 149 (1.34%)
         occurrences all number
    1
    2
    suspected viral infection
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Evidence of consolidation on CXR, coughing up sputum of unknown colour and temperature 01/02/2016- g
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Flu
         subjects affected / exposed
    2 / 150 (1.33%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    Hot and cold sweats at night
         subjects affected / exposed
    0 / 150 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    Bloody ooze from midline wound
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Slight runny nose
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    Shivering and sweaty
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0

    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
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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