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    Clinical Trial Results:
    PreOperative Steroid in Abdominal Wall Reconstruction: A Double-blinded Randomized Clinical Trial

    Summary
    EudraCT number
    		 2015-004916-39
    Trial protocol
    		 DK  
    Global end of trial date
    30 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Feb 2021
    First version publication date
    14 Feb 2021
    Other versions
    Summary report(s)
    		 Final publication

    Trial information

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    Trial identification
    Sponsor protocol code
    2015-806
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02594241
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bispebjerg Hospital
    Sponsor organisation address
    Bispebjerg Bakke 23, Copenhagen NV, Denmark, 2400
    Public contact
    Clinical trial information, Kristian Kiim Jensen, +45 35312201, kristian.kiim.jensen@regionh.dk
    Scientific contact
    Clinical trial information, Kristian Kiim Jensen, +45 35312201, kristian.kiim.jensen@regionh.dk
    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 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    30 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To examine the effects of methylprednisolone on postoperative pain after giant ventral hernia repair.
    Protection of trial subjects
    Patients were treated according to the standards of care for patients undergoing surgery for large ventral hernia.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2016
    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
    Denmark: 42
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    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)
    20
    From 65 to 84 years
    21
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients were included at the Digestive Disease Center, Bispebjerg Hospital from March 1 2016 to May 1 2018.

    Pre-assignment
    Screening details
    		 All patients scheduled for undergoing surgical repair of a large incisional hernia at the Digestive Disease Center, Bispebjerg Hospital were screened.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst
    Blinding implementation details
    An independent physician performed the randomization using a computer-generated sequence with varying block sizes, involving preparing sealed envelopes. Based on randomization, another physician not otherwise involved in the study prepared either the study medication or the placebo and administered it to the patient during induction of anesthesia. Patients, data collectors, and medical staff involved in the treatment of patients were blinded to the study allocation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention
    Arm description
    		 The intervention arm of the trial.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solu-medrol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    125 mg Solu-medrol.

    Arm title
    		 Placebo
    Arm description
    		 The placebo arm of the trial
    Arm type
    		 Placebo

    Investigational medicinal product name
    154 mM NaCl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    154 mM NaCl.

    Number of subjects in period 1
    		Intervention Placebo
    Started
    21
    21
    Completed
    20
    20
    Not completed
    1
    1
         Consent withdrawn by subject
    1
    1

    Baseline characteristics

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

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 42 42
    Age categorical
    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)
    		 20 20
        From 65-84 years
    		 21 21
        85 years and over
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 18 18
        Male
    		 24 24

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 The intervention arm of the trial.

    Reporting group title
    Placebo
    Reporting group description
    		 The placebo arm of the trial

    Subject analysis set title
    Final analysis
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The analysis of patients who completed the trial

    Primary: Pain at rest during the first five postoperative days

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    End point title
    		 Pain at rest during the first five postoperative days
    End point description
    End point type
    Primary
    End point timeframe
    First five postoperative days.
    End point values
    		 Intervention Placebo Final analysis
    Number of subjects analysed
    20
    20
    40
    Units: NRS
        arithmetic mean (standard deviation)
    1.4 ± 1.9
    1.6 ± 1.8
    1.5 ± 1.8
    Statistical analysis title
    		 Overall analysis of pain during first five days
    Statistical analysis description
    Repeated measurement, mixed effect regression, as a Wald test for overall differences between the 2 groups.
    Comparison groups
    Intervention v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    30 days postoperatively
    Adverse event reporting additional description
    All adverse events reported according to the GCP guidelines.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Group of patients receiving the intervention.

    Reporting group title
    Placebo
    Reporting group description
    		 Group receiving placebo

    Serious adverse events
    		 Intervention Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 21 (19.05%)
    1 / 21 (4.76%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Cardiac arrest
    Additional description: Patient had malignant hyperthermia and cardiac arrest during surgery. Patient was rescucitated immediately and recovered fully.
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Readmission
    Additional description: Patients readmitted due to pain from the surgical site, vomiting or gastroenteritis.
         subjects affected / exposed
    4 / 21 (19.05%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Intervention Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 21 (9.52%)
    Skin and subcutaneous tissue disorders
    Skin irritation
    Additional description: Minor itching one postoperative day one.
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 21 (9.52%)
         occurrences all number
    1
    2

    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.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32061400
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