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    Clinical Trial Results:
    Pilot study: Anti-inflammatory effect of preoperative stimulation of the enteric nervous system: a potential new therapeutic intervention to shorten gastroparesis

    Summary
    EudraCT number
    		 2014-000361-52
    Trial protocol
    		 BE  
    Global end of trial date
    27 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Sep 2025
    First version publication date
    10 Sep 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    prucalopride/VNS1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02425774
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 EC UZ Leuven S-number: S56328
    Sponsors
    Sponsor organisation name
    UZ Leuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Guy Boeckxstaens, KULeuven, guy.boeckxstaens@kuleuven.be
    Scientific contact
    Guy Boeckxstaens, KULeuven, guy.boeckxstaens@kuleuven.be
    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
    01 Jan 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate whether prucalopride has anti-inflammatory properties.
    Protection of trial subjects
    Patients signed the informed consent prior any study specific activity.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jul 2014
    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
    Belgium: 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)
    19
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Inclusion: - patients undergoing Pylorus Preserving Pancreatico Duodenectomie (PD), or Pylorus-resecting PD for oncologic reasons - age > 18 Exclusion: - adjuvant radiotherapy - intra-abdominal inflammation - PD for chronic pancreatitis or pancreatic polypeptide producing endocrine tumor - ASA-PS > 3 - Uncontrolled diabetes (>200mg/dl)

    Period 1
    Period 1 title
    Overall baseline 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
    		 Prucalopride
    Arm description
    		 Patients were treated with 2 mg prucalopride (12 and 2 hours prior to surgery) and received sham stimulation at the start and the end of the surgery.
    Arm type
    		 Pharmacological arm

    Investigational medicinal product name
    Prucalopride succinate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2h before surgery: 1*2 mg 12h before surgery: 1*2mg

    Arm title
    		 abdominal Vagus Nerve Stimulation
    Arm description
    		 Patients received abdominal VNS (2min, 20Hz, 2.5 mA, 1ms at the start and end of the surgical procedure) + placebo
    Arm type
    		 Electrical stimulation

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Sham stimulation/placebo
    Arm description
    		 Patients allocated to placebo received sham stimulation at the start and end of surgery, as well as a placebo tablet 12h and 2h before the surgery.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Prucalopride abdominal Vagus Nerve Stimulation Sham stimulation/placebo
    Started
    13
    16
    13
    Completed
    10
    10
    10
    Not completed
    3
    6
    3
         Consent withdrawn by subject
    -
    1
    -
         Screening failure
    -
    -
    1
         Inoperability
    3
    3
    -
         Protocol deviation
    -
    2
    2
    Period 2
    Period 2 title
    2h post-operative
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Prucalopride - 2h postoperative
    Arm description
    		 Patients were treated with 2 mg prucalopride (12 and 2 hours prior to surgery) and received sham stimulation at the start and the end of the surgery.
    Arm type
    		 Pharmacological arm

    Investigational medicinal product name
    Prucalopride succinate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2h before surgery: 1*2 mg 12h before surgery: 1*2mg

    Arm title
    		 abdominal Vagus Nerve Stimulation -2h postoperative
    Arm description
    		 Patients received abdominal VNS (2min, 20Hz, 2.5 mA, 1ms at the start and end of the surgical procedure) + placebo
    Arm type
    		 Electrical stimulation

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Sham stimulation/placebo - 2h postoperative
    Arm description
    		 Patients allocated to placebo received sham stimulation at the start and end of surgery as well as a placebo tablet at 12h and 2h before surgery.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Prucalopride - 2h postoperative abdominal Vagus Nerve Stimulation -2h postoperative Sham stimulation/placebo - 2h postoperative
    Started
    10
    10
    10
    Completed
    10
    10
    10
    Period 3
    Period 3 title
    24h postoperative
    Is this the baseline period?
    		 No
    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
    		 Prucalopride - 24h postoperative
    Arm description
    		 Patients were treated with 2 mg prucalopride (12 and 2 hours prior to surgery) and received sham stimulation at the start and the end of the surgery.
    Arm type
    		 Pharmacological arm

    Investigational medicinal product name
    Prucalopride succinate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2h before surgery: 1*2 mg 12h before surgery: 1*2mg

    Arm title
    		 abdominal Vagus Nerve Stimulation - 24h postoperative
    Arm description
    		 Patients received abdominal VNS (2min, 20Hz, 2.5 mA, 1ms at the start and end of the surgical procedure) + placebo
    Arm type
    		 Electrical stimulation

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Sham stimulation/placebo - 24h postoperative
    Arm description
    		 Patients allocated to placebo received sham stimulation at the start and end of surgery, as well as a placebo tablet 12h and 2h before the surgery.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Prucalopride - 24h postoperative abdominal Vagus Nerve Stimulation - 24h postoperative Sham stimulation/placebo - 24h postoperative
    Started
    10
    10
    10
    Completed
    10
    10
    10
    Period 4
    Period 4 title
    48h postoperative
    Is this the baseline period?
    		 No
    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
    		 Prucalopride - 48h postoperative
    Arm description
    		 Patients were treated with 2 mg prucalopride (12 and 2 hours prior to surgery) and received sham stimulation at the start and the end of the surgery.
    Arm type
    		 Pharmacological arm

    Investigational medicinal product name
    Prucalopride succinate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2h before surgery: 1*2 mg 12h before surgery: 1*2mg

    Arm title
    		 abdominal Vagus Nerve Stimulation - 48h postoperative
    Arm description
    		 Patients received abdominal VNS (2min, 20Hz, 2.5 mA, 1ms at the start and end of the surgical procedure) + placebo
    Arm type
    		 Electrical stimulation

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Sham stimulation/placebo - 48h postoperative
    Arm description
    		 Patients allocated to placebo received sham stimulation at the start and end of surgery, as well as a placebo tablet 12h and 2h before the surgery.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    		Prucalopride - 48h postoperative abdominal Vagus Nerve Stimulation - 48h postoperative Sham stimulation/placebo - 48h postoperative
    Started
    10
    10
    10
    Completed
    10
    10
    10
    Period 5
    Period 5 title
    Postoperative stay
    Is this the baseline period?
    		 No
    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
    		 Prucalopride - postoperative stay
    Arm description
    		 Patients were treated with 2 mg prucalopride (12 and 2 hours prior to surgery) and received sham stimulation at the start and the end of the surgery.
    Arm type
    		 Pharmacological arm

    Investigational medicinal product name
    Prucalopride succinate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2h before surgery: 1*2 mg 12h before surgery: 1*2mg

    Arm title
    		 abdominal Vagus Nerve Stimulation - postoperative stay
    Arm description
    		 Patients received abdominal VNS (2min, 20Hz, 2.5 mA, 1ms at the start and end of the surgical procedure) + placebo
    Arm type
    		 Electrical stimulation

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Sham stimulation/placebo - postoperative stay
    Arm description
    		 Patients allocated to placebo received sham stimulation at the start and end of surgery, as well as a placebo tablet 12h and 2h before the surgery.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 5
    		Prucalopride - postoperative stay abdominal Vagus Nerve Stimulation - postoperative stay Sham stimulation/placebo - postoperative stay
    Started
    10
    10
    10
    Completed
    10
    10
    10

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall baseline period
    Reporting group description
    		 -

    Reporting group values
    		 Overall baseline 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)
    		 19 19
        From 65-84 years
    		 23 23
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 22 22
        Male
    		 20 20

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Prucalopride
    Reporting group description
    		 Patients were treated with 2 mg prucalopride (12 and 2 hours prior to surgery) and received sham stimulation at the start and the end of the surgery.

    Reporting group title
    abdominal Vagus Nerve Stimulation
    Reporting group description
    		 Patients received abdominal VNS (2min, 20Hz, 2.5 mA, 1ms at the start and end of the surgical procedure) + placebo

    Reporting group title
    Sham stimulation/placebo
    Reporting group description
    		 Patients allocated to placebo received sham stimulation at the start and end of surgery, as well as a placebo tablet 12h and 2h before the surgery.
    Reporting group title
    Prucalopride - 2h postoperative
    Reporting group description
    		 Patients were treated with 2 mg prucalopride (12 and 2 hours prior to surgery) and received sham stimulation at the start and the end of the surgery.

    Reporting group title
    abdominal Vagus Nerve Stimulation -2h postoperative
    Reporting group description
    		 Patients received abdominal VNS (2min, 20Hz, 2.5 mA, 1ms at the start and end of the surgical procedure) + placebo

    Reporting group title
    Sham stimulation/placebo - 2h postoperative
    Reporting group description
    		 Patients allocated to placebo received sham stimulation at the start and end of surgery as well as a placebo tablet at 12h and 2h before surgery.
    Reporting group title
    Prucalopride - 24h postoperative
    Reporting group description
    		 Patients were treated with 2 mg prucalopride (12 and 2 hours prior to surgery) and received sham stimulation at the start and the end of the surgery.

    Reporting group title
    abdominal Vagus Nerve Stimulation - 24h postoperative
    Reporting group description
    		 Patients received abdominal VNS (2min, 20Hz, 2.5 mA, 1ms at the start and end of the surgical procedure) + placebo

    Reporting group title
    Sham stimulation/placebo - 24h postoperative
    Reporting group description
    		 Patients allocated to placebo received sham stimulation at the start and end of surgery, as well as a placebo tablet 12h and 2h before the surgery.
    Reporting group title
    Prucalopride - 48h postoperative
    Reporting group description
    		 Patients were treated with 2 mg prucalopride (12 and 2 hours prior to surgery) and received sham stimulation at the start and the end of the surgery.

    Reporting group title
    abdominal Vagus Nerve Stimulation - 48h postoperative
    Reporting group description
    		 Patients received abdominal VNS (2min, 20Hz, 2.5 mA, 1ms at the start and end of the surgical procedure) + placebo

    Reporting group title
    Sham stimulation/placebo - 48h postoperative
    Reporting group description
    		 Patients allocated to placebo received sham stimulation at the start and end of surgery, as well as a placebo tablet 12h and 2h before the surgery.
    Reporting group title
    Prucalopride - postoperative stay
    Reporting group description
    		 Patients were treated with 2 mg prucalopride (12 and 2 hours prior to surgery) and received sham stimulation at the start and the end of the surgery.

    Reporting group title
    abdominal Vagus Nerve Stimulation - postoperative stay
    Reporting group description
    		 Patients received abdominal VNS (2min, 20Hz, 2.5 mA, 1ms at the start and end of the surgical procedure) + placebo

    Reporting group title
    Sham stimulation/placebo - postoperative stay
    Reporting group description
    		 Patients allocated to placebo received sham stimulation at the start and end of surgery, as well as a placebo tablet 12h and 2h before the surgery.

    Primary: Pro-inflammatory genes in muscularis tissue: IL-6

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    End point title
    		 Pro-inflammatory genes in muscularis tissue: IL-6
    End point description
    Relative mRNA gene-expression of IL-6 in the muscularis externa normalised to the housekeeping gene c12fr43. Reporting groups: - reporting group 1: PRUC, 0h - reporting group 2: VNS, 0h - reporting group 3: SHAM/PLAC, 0h - reporting group 4: PRUC, 2h - reporting group 5: VNS, 2h - reporting group 6: SHAM/PLAC, 2h
    End point type
    Primary
    End point timeframe
    Biopsies from the small intestine at the beginning and end of surgery. Small intestine was removed as part of the surgery.
    End point values
    		 Prucalopride abdominal Vagus Nerve Stimulation Sham stimulation/placebo Prucalopride - 2h postoperative abdominal Vagus Nerve Stimulation -2h postoperative Sham stimulation/placebo - 2h postoperative
    Number of subjects analysed
    9 [1]
    10
    10
    9 [2]
    10
    10
    Units: relative unit(s)
        arithmetic mean (standard error)
    0.0307 ( 0.1438 )
    0.02032 ( 0.00662 )
    0.0165 ( 0.006028 )
    0.7192 ( 0.1598 )
    1.044 ( 0.2095 )
    1.742 ( 0.4337 )
    Notes
    [1] - One significant outlier was left out (Grubb’s test for outliers).
    [2] - One significant outlier was left out (Grubb’s test for outliers).
    Statistical analysis title
    		 IL-6 mRNA expr SHAM/PLAC 0h vs PRUC 0h
    Statistical analysis description
    Relative mRNA expression of IL-6 in the muscularis externa, normalised to the housekeeping gene c10fr43
    Comparison groups
    Sham stimulation/placebo v Prucalopride
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [3] - Repeated two-way analysis of variance (ANOVA) with Bonferroni correction for multiple testing
    Statistical analysis title
    		 IL-6 mRNA expr SHAM/PLAC 0h vs VNS 0h
    Statistical analysis description
    Relative mRNA expression of IL-6 in the muscularis externa, normalised to the housekeeping gene c10fr43
    Comparison groups
    abdominal Vagus Nerve Stimulation v Sham stimulation/placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [4]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [4] - Repeated two-way analysis of variance (ANOVA) with Bonferroni correction for multiple testing
    Statistical analysis title
    		 IL-6 mRNA expr VNS 0h vs PRUC 0h
    Statistical analysis description
    Relative mRNA expression of IL-6 in the muscularis externa, normalised to the housekeeping gene c10fr43
    Comparison groups
    Prucalopride v abdominal Vagus Nerve Stimulation
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [5]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [5] - Repeated two-way analysis of variance (ANOVA) with Bonferroni correction for multiple testing
    Statistical analysis title
    		 IL-6 mRNA expr SHAM/PLAC 2h vs PRUC 2h
    Statistical analysis description
    Relative mRNA expression of IL-6 in the muscularis externa, normalised to the housekeeping gene c10fr43
    Comparison groups
    Prucalopride - 2h postoperative v Sham stimulation/placebo - 2h postoperative
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [6]
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [6] - Repeated two-way analysis of variance (ANOVA) with Bonferroni correction for multiple testing
    Statistical analysis title
    		 IL-6 mRNA expr SHAM/PLAC 0h vs VNS 0h
    Statistical analysis description
    Relative mRNA expression of IL-6 in the muscularis externa, normalised to the housekeeping gene c10fr43
    Comparison groups
    abdominal Vagus Nerve Stimulation -2h postoperative v Sham stimulation/placebo - 2h postoperative
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [7]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [7] - Repeated two-way analysis of variance (ANOVA) with Bonferroni correction for multiple testing
    Statistical analysis title
    		 IL-6 mRNA expr VNS 2h vs PRUC 2h
    Statistical analysis description
    Relative mRNA expression of IL-6 in the muscularis externa, normalised to the housekeeping gene c10fr43
    Comparison groups
    Prucalopride - 2h postoperative v abdominal Vagus Nerve Stimulation -2h postoperative
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [8]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [8] - Repeated two-way analysis of variance (ANOVA) with Bonferroni correction for multiple testing

    Primary: Pro-inflammatory genes in muscularis tissue: IL-8

    		 Close Top of page
    End point title
    		 Pro-inflammatory genes in muscularis tissue: IL-8
    End point description
    Relative mRNA gene-expression of IL-6 in the muscularis externa normalised to the housekeeping gene c12fr43. Reporting groups: - reporting group 1: PRUC, 0h - reporting group 2: VNS, 0h - reporting group 3: SHAM/PLAC, 0h - reporting group 4: PRUC, 2h - reporting group 5: VNS, 2h - reporting group 6: SHAM/PLAC, 2h
    End point type
    Primary
    End point timeframe
    Biopsies from the small intestine at the beginning and end of surgery. Small intestine was removed as part of the surgery.
    End point values
    		 Prucalopride abdominal Vagus Nerve Stimulation Sham stimulation/placebo Prucalopride - 2h postoperative abdominal Vagus Nerve Stimulation -2h postoperative Sham stimulation/placebo - 2h postoperative
    Number of subjects analysed
    9 [9]
    10
    10
    9 [10]
    10
    10
    Units: relative unit(s)
        arithmetic mean (standard error)
    0.001979 ( 0.0005383 )
    0.002539 ( 0.0009011 )
    0.003581 ( 0.002201 )
    0.3409 ( 0.1428 )
    0.9788 ( 0.3261 )
    0.9867 ( 0.3046 )
    Notes
    [9] - One significant outlier was left out (Grubb’s test for outliers).
    [10] - One significant outlier was left out (Grubb’s test for outliers).
    Statistical analysis title
    		 IL-8 mRNA expr SHAM/PLAC 0h vs PRUC 0h
    Statistical analysis description
    Relative mRNA expression of IL-8 in the muscularis externa, normalised to the housekeeping gene c10fr43
    Comparison groups
    Prucalopride v Sham stimulation/placebo
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [11]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [11] - Repeated two-way analysis of variance (ANOVA) with Bonferroni correction for multiple testing
    Statistical analysis title
    		 IL-8 mRNA expr SHAM/PLAC 0h vs VNS 0h
    Statistical analysis description
    Relative mRNA gene-expression of IL-8 in the muscularis externa normalised to the housekeeping gene c12fr43.
    Comparison groups
    abdominal Vagus Nerve Stimulation v Sham stimulation/placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [12]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [12] - Repeated two-way analysis of variance (ANOVA) with Bonferroni correction for multiple testing
    Statistical analysis title
    		 IL-8 mRNA expr PRUC 0h vs VNS 0h
    Statistical analysis description
    Relative mRNA gene-expression of IL-8 in the muscularis externa normalised to the housekeeping gene c12fr43.
    Comparison groups
    Prucalopride v abdominal Vagus Nerve Stimulation
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [13]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [13] - Repeated two-way analysis of variance (ANOVA) with Bonferroni correction for multiple testing
    Statistical analysis title
    		 IL-8 mRNA expr SHAM/PLAC 2h vs PRUC 2h
    Comparison groups
    Sham stimulation/placebo - 2h postoperative v Prucalopride - 2h postoperative
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [14]
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [14] - Repeated two-way analysis of variance (ANOVA) with Bonferroni correction for multiple testing
    Statistical analysis title
    		 IL-8 mRNA expr SHAM/PLAC 2h vs VNS 2h
    Comparison groups
    abdominal Vagus Nerve Stimulation -2h postoperative v Sham stimulation/placebo - 2h postoperative
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [15]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [15] - Repeated two-way analysis of variance (ANOVA) with Bonferroni correction for multiple testing
    Statistical analysis title
    		 IL-8 mRNA expr PRUC 2h vs VNS 2h
    Comparison groups
    Prucalopride - 2h postoperative v abdominal Vagus Nerve Stimulation -2h postoperative
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [16]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [16] - Repeated two-way analysis of variance (ANOVA) with Bonferroni correction for multiple testing

    Primary: IL-6 in serum, 0h (baseline)

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    End point title
    		 IL-6 in serum, 0h (baseline)
    End point description
    All statistical analysis performed for this endpoint were not significant. All analysis were pre-specified, equivalence. The analysis was done with Kruskall-wallis with Dunn's correction per timepoint (0, 2, 24, 48 hours postoperative). - IL-6 serum SHAM/PLAC 0h vs PRUC 0h: p>0.05 - IL-6 serum SHAM/PLAC 0h vs VNS 0h: p>0.05 - IL-6 serum PRUC 0h vs VNS 0h: p>0.05
    End point type
    Primary
    End point timeframe
    IL-6 in serum was measured at following time points: 0h, 2h, 24h and 48h after surgery.
    End point values
    		 Prucalopride abdominal Vagus Nerve Stimulation Sham stimulation/placebo
    Number of subjects analysed
    10
    10
    10
    Units: picogram(s)/millilitre
        median (full range (min-max))
    2.36667 (0.55915 to 8.988483)
    3.7465015 (0.764547 to 12.74663)
    2.1877395 (0.617229 to 12.41471)
    Statistical analysis title
    		 IL-6 serum SHAM/PLAC 0h vs PRUC 0h
    Statistical analysis description
    Kruskall-Wallis with Dunn's correction per timepoint (0,2,24,48 hours)
    Comparison groups
    Prucalopride v Sham stimulation/placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: IL-6 in serum, 2h postoperative

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    End point title
    		 IL-6 in serum, 2h postoperative
    End point description
    All statistical analysis performed for this endpoint were not significant. All analysis were pre-specified, equivalence. The analysis was done with Kruskall-wallis with Dunn's correction per timepoint (0, 2, 24, 48 hours postoperative). - IL-6 serum SHAM/PLAC 2h vs PRUC 2h: p>0.05 - IL-6 serum SHAM/PLAC 2h vs VNS 2h: p>0.05 - IL-6 serum PRUC 2h vs VNS 2h: p>0.05
    End point type
    Primary
    End point timeframe
    IL-6 in serum was measured at following time points: 0h, 2h, 24h and 48h after surgery.
    End point values
    		 Prucalopride - 2h postoperative abdominal Vagus Nerve Stimulation -2h postoperative Sham stimulation/placebo - 2h postoperative
    Number of subjects analysed
    10
    10
    10
    Units: picogram(s)/millilitre
        median (full range (min-max))
    44.81418 (7.331739 to 80.13982)
    42.19487 (10.7193 to 226.3681)
    45.514405 (18.64029 to 176.1539)
    Statistical analysis title
    		 IL-6 serum SHAM/PLAC 2h vs PRUC 2h
    Comparison groups
    Sham stimulation/placebo - 2h postoperative v Prucalopride - 2h postoperative
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: IL-6 in serum, 24h postoperative

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    End point title
    		 IL-6 in serum, 24h postoperative
    End point description
    All statistical analysis performed for this endpoint were not significant. All analysis were pre-specified, equivalence. The analysis was done with Kruskall-wallis with Dunn's correction per timepoint (0, 2, 24, 48 hours postoperative). - IL-6 serum SHAM/PLAC 24h vs PRUC 24h: p>0.05 - IL-6 serum SHAM/PLAC 24h vs VNS 24h: p>0.05 - IL-6 serum PRUC 24h vs VNS 24h: p>0.05
    End point type
    Primary
    End point timeframe
    IL-6 in serum was measured at following time points: 0h, 2h, 24h and 48h after surgery.
    End point values
    		 Prucalopride - 24h postoperative abdominal Vagus Nerve Stimulation - 24h postoperative Sham stimulation/placebo - 24h postoperative
    Number of subjects analysed
    10
    10
    10
    Units: picogram(s)/millilitre
        median (full range (min-max))
    38.24138 (12.13932 to 384.1603)
    104.67677 (4.030243 to 228.1577)
    44.35539 (16.2332 to 87.88212)
    Statistical analysis title
    		 IL-6 serum SHAM/PLAC 24h vs PRUC 24h
    Comparison groups
    Prucalopride - 24h postoperative v Sham stimulation/placebo - 24h postoperative
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: IL-6 in serum, 48h postoperative

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    End point title
    		 IL-6 in serum, 48h postoperative
    End point description
    All statistical analysis performed for this endpoint were not significant. All analysis were pre-specified, equivalence. The analysis was done with Kruskall-wallis with Dunn's correction per timepoint (0, 2, 24, 48 hours postoperative). - IL-6 serum SHAM/PLAC 48h vs PRUC 48h: p>0.05 - IL-6 serum SHAM/PLAC 48h vs VNS 48h: p>0.05 - IL-6 serum PRUC 48h vs VNS 48h: p>0.05
    End point type
    Primary
    End point timeframe
    IL-6 in serum was measured at following time points: 0h, 2h, 24h and 48h after surgery.
    End point values
    		 Prucalopride - 48h postoperative abdominal Vagus Nerve Stimulation - 48h postoperative Sham stimulation/placebo - 48h postoperative
    Number of subjects analysed
    10
    10
    10
    Units: picogram(s)/millilitre
        median (full range (min-max))
    20.273315 (5.037318 to 116.5325)
    24.37853 (6.258462 to 456.0946)
    21.307805 (8.422992 to 82.77205)
    Statistical analysis title
    		 IL-6 serum SHAM/PLAC 48h vs PRUC 48h
    Statistical analysis description
    Kruskall-Wallis with Dunn's correction per timepoint (0,2,24,48 hours)
    Comparison groups
    Sham stimulation/placebo - 48h postoperative v Prucalopride - 48h postoperative
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: IL-8 in serum, 0h (baseline)

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    End point title
    		 IL-8 in serum, 0h (baseline)
    End point description
    All statistical analysis performed for this endpoint were not significant. All analysis were pre-specified, equivalence. The analysis was done with Kruskall-wallis with Dunn's correction per timepoint (0, 2, 24, 48 hours postoperative). - IL-8 serum SHAM/PLAC 0h vs PRUC 0h: p>0.05 - IL-8 serum SHAM/PLAC 0h vs VNS 0h: p>0.05 - IL-8 serum PRUC 0h vs VNS 0h: p>0.05
    End point type
    Primary
    End point timeframe
    IL-8 in serum was measured at following time points: 0h, 2h, 24h and 48h after surgery.
    End point values
    		 Prucalopride abdominal Vagus Nerve Stimulation Sham stimulation/placebo
    Number of subjects analysed
    10
    10
    10
    Units: picogram(s)/millilitre
        median (full range (min-max))
    22.81154 (9.915079 to 106.0631)
    21.90382 (10.08026 to 254.0737)
    32.21309 (7.325124 to 373.6089)
    Statistical analysis title
    		 IL-8 serum SHAM/PLAC 0h vs PRUC 0h
    Statistical analysis description
    Kruskall-Wallis with Dunn's correction per timepoint (0,2,24,48 hours)
    Comparison groups
    Sham stimulation/placebo v Prucalopride
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: IL-8 in serum, 2h postoperative

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    End point title
    		 IL-8 in serum, 2h postoperative
    End point description
    All statistical analysis performed for this endpoint were not significant. All analysis were pre-specified, equivalence. The analysis was done with Kruskall-wallis with Dunn's correction per timepoint (0, 2, 24, 48 hours postoperative). - IL-8 serum SHAM/PLAC 2h vs PRUC 2h: p>0.05 - IL-8 serum SHAM/PLAC 2h vs VNS 2h: p>0.05 - IL-8 serum PRUC 2h vs VNS 2h: p>0.05
    End point type
    Primary
    End point timeframe
    IL-8 in serum was measured at following time points: 0h, 2h, 24h and 48h after surgery.
    End point values
    		 Prucalopride - 2h postoperative abdominal Vagus Nerve Stimulation -2h postoperative Sham stimulation/placebo - 2h postoperative
    Number of subjects analysed
    10
    10
    10
    Units: picogram(s)/millilitre
        median (full range (min-max))
    48.73039 (14.997 to 147.3282)
    50.9942 (11.64753 to 259.1205)
    84.6272 (11.72516 to 410.5159)
    Statistical analysis title
    		 IL-8 serum SHAM/PLAC 2h vs PRUC 2h
    Statistical analysis description
    Kruskall-Wallis with Dunn's correction per timepoint (0,2,24,48 hours)
    Comparison groups
    Prucalopride - 2h postoperative v Sham stimulation/placebo - 2h postoperative
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: IL-8 in serum, 24h postoperative

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    End point title
    		 IL-8 in serum, 24h postoperative
    End point description
    All statistical analysis performed for this endpoint were not significant. All analysis were pre-specified, equivalence. The analysis was done with Kruskall-wallis with Dunn's correction per timepoint (0, 2, 24, 48 hours postoperative). - IL-8 serum SHAM/PLAC 24h vs PRUC 24h: p>0.05 - IL-8 serum SHAM/PLAC 24h vs VNS 24h: p>0.05 - IL-8 serum PRUC 24h vs VNS 24h: p>0.05
    End point type
    Primary
    End point timeframe
    IL-8 in serum was measured at following time points: 0h, 2h, 24h and 48h after surgery.
    End point values
    		 Prucalopride - 24h postoperative abdominal Vagus Nerve Stimulation - 24h postoperative Sham stimulation/placebo - 24h postoperative
    Number of subjects analysed
    10
    10
    10
    Units: picogram(s)/millilitre
        median (full range (min-max))
    25.147385 (13.00137 to 174.2133)
    30.29369 (6.455689 to 272.6213)
    45.30166 (19.61076 to 92.94854)
    Statistical analysis title
    		 IL-8 serum SHAM/PLAC 24h vs PRUC 24h
    Statistical analysis description
    Kruskall-Wallis with Dunn's correction per timepoint (0,2,24,48 hours)
    Comparison groups
    Sham stimulation/placebo - 24h postoperative v Prucalopride - 24h postoperative
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: IL-8 in serum, 48h postoperative

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    End point title
    		 IL-8 in serum, 48h postoperative
    End point description
    All statistical analysis performed for this endpoint were not significant. All analysis were pre-specified, equivalence. The analysis was done with Kruskall-wallis with Dunn's correction per timepoint (0, 2, 24, 48 hours postoperative). - IL-8 serum SHAM/PLAC 48h vs PRUC 48h: p>0.05 - IL-8 serum SHAM/PLAC 48h vs VNS 48h: p>0.05 - IL-8 serum PRUC 48h vs VNS 48h: p>0.05
    End point type
    Primary
    End point timeframe
    IL-8 in serum was measured at following time points: 0h, 2h, 24h and 48h after surgery.
    End point values
    		 Prucalopride - 48h postoperative abdominal Vagus Nerve Stimulation - 48h postoperative Sham stimulation/placebo - 48h postoperative
    Number of subjects analysed
    10
    10
    10
    Units: picogram(s)/millilitre
        median (full range (min-max))
    16.944955 (9.331727 to 110)
    17.68162 (8.990667 to 140.5201)
    27.99449 (15.92338 to 42.12079)
    Statistical analysis title
    		 IL-8 serum SHAM/PLAC 48h vs PRUC 48h
    Statistical analysis description
    Kruskall-Wallis with Dunn's correction per timepoint (0,2,24,48 hours)
    Comparison groups
    Prucalopride - 48h postoperative v Sham stimulation/placebo - 48h postoperative
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: TNF-alpha in serum, 0h (baseline)

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    End point title
    		 TNF-alpha in serum, 0h (baseline)
    End point description
    All statistical analysis performed for this endpoint were not significant. All analysis were pre-specified, equivalence. The analysis was done with Kruskall-wallis with Dunn's correction per timepoint (0, 2, 24, 48 hours postoperative). - TNFα serum SHAM/PLAC 0h vs PRUC 0h: p>0.05 - TNFα serum SHAM/PLAC 0h vs VNS 0h: p>0.05 - TNFα serum PRUC 0h vs VNS 0h: p>0.05
    End point type
    Primary
    End point timeframe
    TNFα in serum was measured at following time points: 0h, 2h, 24h and 48h after surgery.
    End point values
    		 Prucalopride abdominal Vagus Nerve Stimulation Sham stimulation/placebo
    Number of subjects analysed
    10
    10
    10
    Units: picogram(s)/millilitre
        median (full range (min-max))
    3.023515 (1.632236 to 5.544945)
    3.847894 (2.377238 to 5.25516)
    3.101691 (1.599626 to 12.31394)
    Statistical analysis title
    		 TNFα serum SHAM/PLAC 0h vs PRUC 0h
    Statistical analysis description
    Kruskall-Wallis with Dunn's correction per timepoint (0,2,24,48 hours)
    Comparison groups
    Prucalopride v Sham stimulation/placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: TNF-alpha in serum, 2h postoperative

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    End point title
    		 TNF-alpha in serum, 2h postoperative
    End point description
    All statistical analysis performed for this endpoint were not significant. All analysis were pre-specified, equivalence. The analysis was done with Kruskall-wallis with Dunn's correction per timepoint (0, 2, 24, 48 hours postoperative). - TNFα serum SHAM/PLAC 2h vs PRUC 2h: p>0.05 - TNFα serum SHAM/PLAC 2h vs VNS 2h: p>0.05 - TNFα serum PRUC 2h vs VNS 2h: p>0.05
    End point type
    Primary
    End point timeframe
    TNFα in serum was measured at following time points: 0h, 2h, 24h and 48h after surgery.
    End point values
    		 Prucalopride - 2h postoperative abdominal Vagus Nerve Stimulation -2h postoperative Sham stimulation/placebo - 2h postoperative
    Number of subjects analysed
    10
    10
    10
    Units: picogram(s)/millilitre
        median (full range (min-max))
    3.188469 (0.985607 to 6.316739)
    3.23437 (2.080917 to 4.639587)
    4.0991915 (1.224778 to 8.70794)
    Statistical analysis title
    		 TNFα serum SHAM/PLAC 2h vs PRUC 2h
    Statistical analysis description
    Kruskall-Wallis with Dunn's correction per timepoint (0,2,24,48 hours)
    Comparison groups
    Prucalopride - 2h postoperative v Sham stimulation/placebo - 2h postoperative
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: TNF-alpha in serum, 24h postoperative

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    End point title
    		 TNF-alpha in serum, 24h postoperative
    End point description
    All statistical analysis performed for this endpoint were not significant. All analysis were pre-specified, equivalence. The analysis was done with Kruskall-wallis with Dunn's correction per timepoint (0, 2, 24, 48 hours postoperative). - TNFα serum SHAM/PLAC 24h vs PRUC 24h: p>0.05 - TNFα serum SHAM/PLAC 24h vs VNS 24h: p>0.05 - TNFα serum PRUC 24h vs VNS 24h: p>0.05
    End point type
    Primary
    End point timeframe
    TNFα in serum was measured at following time points: 0h, 2h, 24h and 48h after surgery.
    End point values
    		 Prucalopride - 24h postoperative abdominal Vagus Nerve Stimulation - 24h postoperative Sham stimulation/placebo - 24h postoperative
    Number of subjects analysed
    10
    10
    10
    Units: picogram(s)/millilitre
        median (full range (min-max))
    2.7994345 (1.417976 to 4.901272)
    3.0247145 (1.50724 to 9.428092)
    3.85771 (2.389357 to 5.429664)
    Statistical analysis title
    		 TNFα serum SHAM/PLAC 24h vs PRUC 24h
    Statistical analysis description
    Kruskall-Wallis with Dunn's correction per timepoint (0,2,24,48 hours)
    Comparison groups
    Prucalopride - 24h postoperative v Sham stimulation/placebo - 24h postoperative
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: TNF-alpha in serum, 48h postoperative

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    End point title
    		 TNF-alpha in serum, 48h postoperative
    End point description
    All statistical analysis performed for this endpoint were not significant. All analysis were pre-specified, equivalence. The analysis was done with Kruskall-wallis with Dunn's correction per timepoint (0, 2, 24, 48 hours postoperative). - TNFα serum SHAM/PLAC 48h vs PRUC 48h: p>0.05 - TNFα serum SHAM/PLAC 48h vs VNS 48h: p>0.05 - TNFα serum PRUC 48h vs VNS 48h: p>0.05
    End point type
    Primary
    End point timeframe
    TNFα in serum was measured at following time points: 0h, 2h, 24h and 48h after surgery.
    End point values
    		 Prucalopride - 48h postoperative abdominal Vagus Nerve Stimulation - 48h postoperative Sham stimulation/placebo - 48h postoperative
    Number of subjects analysed
    10
    10
    10
    Units: relative unit(s)
        median (full range (min-max))
    3.270561 (1.367377 to 5.21516)
    3.519517 (2.071589 to 10.1279)
    3.8145755 (2.131474 to 5.181907)
    Statistical analysis title
    		 TNFα serum SHAM/PLAC 48h vs PRUC 48h
    Statistical analysis description
    Kruskall-Wallis with Dunn's correction per timepoint (0,2,24,48 hours)
    Comparison groups
    Prucalopride - 48h postoperative v Sham stimulation/placebo - 48h postoperative
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Secondary: Time to first defecation

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    End point title
    		 Time to first defecation
    End point description
    End point type
    Secondary
    End point timeframe
    Number of days postoperative until first defecation are measured.
    End point values
    		 Prucalopride - postoperative stay abdominal Vagus Nerve Stimulation - postoperative stay Sham stimulation/placebo - postoperative stay
    Number of subjects analysed
    7 [17]
    7 [18]
    9 [19]
    Units: day
        arithmetic mean (standard deviation)
    6.125 ( 1.937 )
    5.75 ( 2.191 )
    8.208 ( 4.771 )
    Notes
    [17] - Patients (3) with site specific complications were excluded from the analysis.
    [18] - Patients (3) with site specific complications were excluded from the analysis.
    [19] - Patients (1) with site specific complications were excluded from the analysis.
    Statistical analysis title
    		 time to first defecation: SHAM/PLAC vs PRUC
    Statistical analysis description
    One-way ANOVA with Bonferroni correction for multiple testing
    Comparison groups
    Sham stimulation/placebo - postoperative stay v Prucalopride - postoperative stay
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 time to first defecation: SHAM/PLAC vs VNS
    Statistical analysis description
    One-way ANOVA with Bonferroni correction for multiple testing
    Comparison groups
    abdominal Vagus Nerve Stimulation - postoperative stay v Sham stimulation/placebo - postoperative stay
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 time to first defecation: PRUC vs VNS
    Statistical analysis description
    One-way ANOVA with Bonferroni correction for multiple testing
    Comparison groups
    Prucalopride - postoperative stay v abdominal Vagus Nerve Stimulation - postoperative stay
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: Time to discharge

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    End point title
    		 Time to discharge
    End point description
    End point type
    Secondary
    End point timeframe
    Time (days) postoperative until discharge is captured
    End point values
    		 Prucalopride - postoperative stay abdominal Vagus Nerve Stimulation - postoperative stay Sham stimulation/placebo - postoperative stay
    Number of subjects analysed
    7 [20]
    7 [21]
    9 [22]
    Units: day
        arithmetic mean (standard deviation)
    11.14 ( 3.89 )
    16.1 ( 2.919 )
    16.75 ( 5.591 )
    Notes
    [20] - Patients (3) with site specific complications were excluded from the analysis.
    [21] - Patients (3) with site specific complications were excluded from the analysis.
    [22] - Patients (1) with site specific complications were excluded from the analysis.
    Statistical analysis title
    		 time to discharge: SHAM/PLAC vs VNS
    Comparison groups
    abdominal Vagus Nerve Stimulation - postoperative stay v Sham stimulation/placebo - postoperative stay
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [23]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [23] - One-way ANOVA with Bonferroni correction for multiple testing
    Statistical analysis title
    		 time to discharge: SHAM/PLAC vs PRUC
    Comparison groups
    Prucalopride - postoperative stay v Sham stimulation/placebo - postoperative stay
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [24]
    P-value
    		 < 0.05 [25]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [24] - One-way ANOVA with Bonferroni correction for multiple testing
    [25] - Significant shorter time to discharge in the prucalopride group in comparison to the sham/placebo group.
    Statistical analysis title
    		 time to discharge: VNS vs PRUC
    Comparison groups
    abdominal Vagus Nerve Stimulation - postoperative stay v Prucalopride - postoperative stay
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [26]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [26] - One-way ANOVA with Bonferroni correction for multiple testing

    Secondary: Time to first solids after surgery

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    End point title
    		 Time to first solids after surgery
    End point description
    End point type
    Secondary
    End point timeframe
    Time (days) postoperative to first solids was captured
    End point values
    		 Prucalopride - postoperative stay abdominal Vagus Nerve Stimulation - postoperative stay Sham stimulation/placebo - postoperative stay
    Number of subjects analysed
    7 [27]
    7 [28]
    9 [29]
    Units: day
        arithmetic mean (standard deviation)
    3.765 ( 0.7732 )
    9.881 ( 3.19 )
    10.44 ( 5.741 )
    Notes
    [27] - Patients (3) with site specific complications were excluded from the analysis.
    [28] - Patients (3) with site specific complications were excluded from the analysis.
    [29] - Patients (1) with site specific complications were excluded from the analysis.
    Statistical analysis title
    		 time to first solids: SHAM/PLAC vs PRUC
    Statistical analysis description
    One-way ANOVA with Bonferroni correction for multiple testing
    Comparison groups
    Sham stimulation/placebo - postoperative stay v Prucalopride - postoperative stay
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.01 [30]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [30] - Significant shorter time until first solids in the prucalopride group in comparison to the sham/placebo group.
    Statistical analysis title
    		 time to first solids: SHAM/PLAC vs VNS
    Statistical analysis description
    One-way ANOVA with Bonferroni correction for multiple testing
    Comparison groups
    Sham stimulation/placebo - postoperative stay v abdominal Vagus Nerve Stimulation - postoperative stay
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 time to first solids: PRUC vs VNS
    Statistical analysis description
    One-way ANOVA with Bonferroni correction for multiple testing
    Comparison groups
    Prucalopride - postoperative stay v abdominal Vagus Nerve Stimulation - postoperative stay
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05 [31]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [31] - Significant shorter time until first solids in the prucalopride group in comparison to the vns group.

    Secondary: Time to nasogastric tube (NGT) removal

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    End point title
    		 Time to nasogastric tube (NGT) removal
    End point description
    End point type
    Secondary
    End point timeframe
    Time postoperative until nasogastric tube (NGT) removal was captured
    End point values
    		 Prucalopride - postoperative stay abdominal Vagus Nerve Stimulation - postoperative stay Sham stimulation/placebo - postoperative stay
    Number of subjects analysed
    7 [32]
    7 [33]
    9 [34]
    Units: day
        arithmetic mean (standard deviation)
    2.82 ( 0.88 )
    7.6 ( 4.18 )
    8.97 ( 6.55 )
    Notes
    [32] - Patients (3) with site specific complications were excluded from the analysis.
    [33] - Patients (3) with site specific complications were excluded from the analysis.
    [34] - Patients (1) with site specific complications were excluded from the analysis.
    Statistical analysis title
    		 time to nasogastric tube remova: SHAM/PLAC vs PRUC
    Statistical analysis description
    One-way ANOVA with Bonferroni correction for multiple testing
    Comparison groups
    Sham stimulation/placebo - postoperative stay v Prucalopride - postoperative stay
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05 [35]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [35] - Significant shorter time to gastric tube removal in prucalopride group, in comparison to the sham/placebo group.
    Statistical analysis title
    		 time to nasogastric tube removal: SHAM/PLAC vs VNS
    Comparison groups
    abdominal Vagus Nerve Stimulation - postoperative stay v Sham stimulation/placebo - postoperative stay
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [36]
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [36] - One-way ANOVA with Bonferroni correction for multiple testing
    Statistical analysis title
    		 time to nasogastric tube removal: PRUC vs VNS
    Statistical analysis description
    One-way ANOVA with Bonferroni correction for multiple testing
    Comparison groups
    Prucalopride - postoperative stay v abdominal Vagus Nerve Stimulation - postoperative stay
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: Time to first solids + first defecation

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    End point title
    		 Time to first solids + first defecation
    End point description
    Time (days) to the occurrence of both first defecation and first solid food intake, defined as the time to the later of the two events for analysis.
    End point type
    Secondary
    End point timeframe
    Time (postoperative) to first solids and first defecation, in days was measured
    End point values
    		 Prucalopride - postoperative stay abdominal Vagus Nerve Stimulation - postoperative stay Sham stimulation/placebo - postoperative stay
    Number of subjects analysed
    7 [37]
    7 [38]
    9 [39]
    Units: day
        arithmetic mean (standard deviation)
    6.298 ( 1.644 )
    9.893 ( 3.185 )
    10.49 ( 5.784 )
    Notes
    [37] - Patients (3) with site specific complications were excluded from the analysis.
    [38] - Patients (3) with site specific complications were excluded from the analysis.
    [39] - Patients (1) with site specific complications were excluded from the analysis.
    Statistical analysis title
    		 time to first solids+defecation: SHAM/PLAC vs PRUC
    Statistical analysis description
    One-way ANOVA with Bonferroni correction for multiple testing
    Comparison groups
    Prucalopride - postoperative stay v Sham stimulation/placebo - postoperative stay
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 time to first solids+defecation: SHAM/PLAC vs VNS
    Statistical analysis description
    One-way ANOVA with Bonferroni correction for multiple testing
    Comparison groups
    Sham stimulation/placebo - postoperative stay v abdominal Vagus Nerve Stimulation - postoperative stay
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 time to first solids+defecation: PRUC vs VNS
    Statistical analysis description
    One-way ANOVA with Bonferroni correction for multiple testing
    Comparison groups
    Prucalopride - postoperative stay v abdominal Vagus Nerve Stimulation - postoperative stay
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The adverse events were assessed daily until discharge.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 No dictionary used
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Prucalopride
    Reporting group description
    		 Patients were treated with 2 mg prucalopride (12 and 2 hours prior to surgery) and received sham stimulation at the start and the end of the surgery.

    Reporting group title
    abdominal Vagus Nerve Stimulation
    Reporting group description
    		 Patients received abdominal VNS (2min, 20Hz, 2.5 mA, 1ms at the start and end of the surgical procedure) + placebo

    Reporting group title
    Sham stimulation/placebo
    Reporting group description
    		 Patients allocated to placebo received sham stimulation at the start and end of surgery

    Serious adverse events
    		 Prucalopride abdominal Vagus Nerve Stimulation Sham stimulation/placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 10 (20.00%)
    3 / 10 (30.00%)
    2 / 10 (20.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Cardiac disorders
    Hypotension
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastroparesis postoperative
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
    Additional description: Severe hypoxia leading to prolongation of hospitalisation/admission to ITE
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Prucalopride abdominal Vagus Nerve Stimulation Sham stimulation/placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 10 (40.00%)
    8 / 10 (80.00%)
    7 / 10 (70.00%)
    Investigations
    Transfusion
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 10 (20.00%)
    3 / 10 (30.00%)
    2 / 10 (20.00%)
         occurrences all number
    3
    3
    2
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    3 / 10 (30.00%)
         occurrences all number
    0
    1
    3
    Skin and subcutaneous tissue disorders
    Drain site complication
    Additional description: infected wounds fluid in drain
         subjects affected / exposed
    3 / 10 (30.00%)
    2 / 10 (20.00%)
    1 / 10 (10.00%)
         occurrences all number
    3
    2
    1
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    2
    0
    Infections and infestations
    Catheter site infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    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 reported
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