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    Clinical Trial Results:
    Preoperativ dexamethasone for patients undergoing laparoscopy for suspected appendicitis.

    Summary
    EudraCT number
    		 2014-005040-18
    Trial protocol
    		 DK  
    Global end of trial date
    23 Oct 2015

    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
    2014-707
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Nordsjællands Hospital
    Sponsor organisation address
    Dyrehavevej 29, Hillerød, Denmark, 3400
    Public contact
    Jakob Kleif, Kirurgisk afdeling, Nordsjællands Hospital, +45 48292005, jakob.kleif@regionh.dk
    Scientific contact
    Jakob Kleif, Kirurgisk afdeling, Nordsjællands Hospital, +45 48292005, 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
    26 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To test whether preoperative dexamethason can reduce postoperativ nausea and vomiting and enhance postoperativ recovery after a laparoscopy for suspected appendicitis.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2015
    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: 119
    Worldwide total number of subjects
    119
    EEA total number of subjects
    119
    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)
    105
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment between 30.04.2015 to 02.09.2016

    Pre-assignment
    Screening details
    		 170 patients screenet by attending surgeon. 120 allocated, one patient withdrew consent prior to receiving intervention. 119 patients included.

    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
    		 Dexamethasone
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexamethasone
    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 Dexamethasone 4mg/ml

    Number of subjects in period 1
    		Placebo Dexamethasone
    Started
    60
    59
    Completed
    59
    57
    Not completed
    1
    2
         Consent withdrawn by subject
    1
    1
         Protocol deviation
    -
    1

    Baseline characteristics

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

    Reporting group title
    Dexamethasone
    Reporting group description
    		 -

    Reporting group values
    		 Placebo Dexamethasone Total
    Number of subjects
    		 60 59 119
    Age categorical
    Units: Subjects
        Adults (>17 years)
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 38 (24 to 53) 41 (27 to 57) -
    Gender categorical
    Units: Subjects
        Female
    		 36 27 63
        Male
    		 24 32 56

    End points

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

    Reporting group title
    Dexamethasone
    Reporting group description
    		 -

    Primary: PONV

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    End point title
    		 PONV
    End point description
    Postoperative nausea or vomiting.
    End point type
    Primary
    End point timeframe
    During first postoperative day
    End point values
    		 Placebo Dexamethasone
    Number of subjects analysed
    59
    57
    Units: Patients
    37
    27
    Statistical analysis title
    		 PONV
    Statistical analysis description
    Logistic regression
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 33

    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
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Dexamethasone
    Reporting group description
    		 -

    Reporting group title
    Placebo (saline)
    Reporting group description
    		 30 days postoperative

    Serious adverse events
    		 Dexamethasone Placebo (saline)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 59 (10.17%)
    5 / 60 (8.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Others
         subjects affected / exposed
    6 / 59 (10.17%)
    5 / 60 (8.33%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Dexamethasone Placebo (saline)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 59 (28.81%)
    20 / 60 (33.33%)
    General disorders and administration site conditions
    Others
         subjects affected / exposed
    17 / 59 (28.81%)
    20 / 60 (33.33%)
         occurrences all number
    17
    20

    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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