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    Clinical Trial Results:
    Preoperative methylprednisolone to patients suspected of appendicitis undergoing laparoscopy.

    Summary
    EudraCT number
    		 2015-004800-46
    Trial protocol
    		 DK  
    Global end of trial date
    23 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Nov 2017
    First version publication date
    22 Nov 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2015-810
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Kirurgisk Afdeling, Nordsjællands Hospital
    Sponsor organisation address
    Dyrehavevej 29, Hillerød, Denmark,
    Public contact
    Jakob Kleif, Kirurgisk Afdeling, Nordsjællands Hospital, jakob.kleif@regionh.dk
    Scientific contact
    Jakob Kleif, Kirurgisk Afdeling, Nordsjællands Hospital, jakob.kleif@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
    23 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To test whether preoperative methylprednisolone can reduce postoperative pain after laparoscopy for suspected appendicitis.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 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: 78
    Worldwide total number of subjects
    78
    EEA total number of subjects
    78
    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)
    72
    From 65 to 84 years
    5
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 From 12.04.2016 to 24.08.2016 127 were eligible, 78 patients were included and randomised.

    Pre-assignment
    Screening details
    		 Screen by attending surgeon.

    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, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    2 ml Saline

    Arm title
    		 Methylprednisolone
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Methylprednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    125 mg (2 ml) Methylprednisolone.

    Number of subjects in period 1
    		Placebo Methylprednisolone
    Started
    40
    38
    Completed
    40
    38

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Methylprednisolone
    Reporting group description
    		 -

    Primary: Pain during the first 3 postoperative days

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    End point title
    		 Pain during the first 3 postoperative days
    End point description
    The analysis was made using repeated measures. Therefore the mean for each study group is not reported. (Written as zero because the system needs a value).
    End point type
    Primary
    End point timeframe
    3 first postoperative days
    End point values
    		 Placebo Methylprednisolone
    Number of subjects analysed
    40
    38
    Units: VAS
        number (confidence interval 95%)
    0 (0 to 0)
    0 (0 to 0)
    Statistical analysis title
    		 Difference in Pain the first 3 postoperative days
    Comparison groups
    Placebo v Methylprednisolone
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.571
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.9

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    30 days postoperative.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Clavien-dindo
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Placebo (saline)
    Reporting group description
    		 -

    Reporting group title
    Methylprednisolon
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo (saline) Methylprednisolon
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 40 (12.50%)
    2 / 38 (5.26%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Other
         subjects affected / exposed
    5 / 40 (12.50%)
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo (saline) Methylprednisolon
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 40 (27.50%)
    9 / 38 (23.68%)
    General disorders and administration site conditions
    Other
         subjects affected / exposed
    11 / 40 (27.50%)
    9 / 38 (23.68%)
         occurrences all number
    11
    9

    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
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    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.

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