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Prucalopride in Postoperative Ileus

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ClinicalTrials.gov Identifier: NCT02947269
Recruitment Status : Unknown
Verified October 2017 by A/Prof Ian Bissett, University of Auckland, New Zealand.
Recruitment status was:  Recruiting
First Posted : October 27, 2016
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
A/Prof Ian Bissett, University of Auckland, New Zealand

Tracking Information
First Submitted Date  ICMJE October 23, 2016
First Posted Date  ICMJE October 27, 2016
Last Update Posted Date October 27, 2017
Actual Study Start Date  ICMJE October 25, 2017
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2016)
Time until recovery of gastrointestinal function [ Time Frame: From date of surgery until discharge from hospital (14 days on average) ]
Recovery of GI function is defined by the later time point (in days) of time to passage of stool AND time to tolerance of a solid or semi-solid diet. Patients will be reviewed twice per day using a structured questionnaire.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2017)
  • Time until passage of stool (in days) [ Time Frame: From date of surgery until discharge from hospital (14 days on average) ]
  • Time until passage of flatus (in days) [ Time Frame: From date of surgery until discharge from hospital (14 days on average) ]
  • Time until tolerance of solid oral diet (in days) [ Time Frame: From date of surgery until discharge from hospital (14 days on average) ]
  • Presence of prolonged postoperative ileus [ Time Frame: From date of surgery until discharge from hospital (14 days on average) ]
    Prolonged postoperative ileus is defined as presence of 2 or more of the following criteria on or after day 4 postoperatively: nausea or vomiting, inability to tolerate a solid or semi-solid oral diet, abdominal distension, absence of flatus and stool, radiological evidence of ileus.
  • Levels of serum inflammatory markers (in pg/mL) [ Time Frame: Inflammatory markers will be collected preoperatively, day 1 and 3 postoperatively. Blood samples will be stored after collection for later testing (up to 1 year). ]
    Markers to be tested: CRP, IL1beta, IL6, IL8, IL12, TNFalpha
  • Length of postoperative stay (in days) [ Time Frame: From date of surgery until discharge from hospital (14 days on average) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2016)
  • Time until passage of stool (in days) [ Time Frame: From date of surgery until discharge from hospital (14 days on average) ]
  • Time until passage of flatus (in days) [ Time Frame: From date of surgery until discharge from hospital (14 days on average) ]
  • Time until tolerance of solid oral diet (in days) [ Time Frame: From date of surgery until discharge from hospital (14 days on average) ]
  • Presence of prolonged postoperative ileus [ Time Frame: From date of surgery until discharge from hospital (14 days on average) ]
    Prolonged postoperative ileus is defined as presence of 2 or more of the following criteria on or after day 4 postoperatively: nausea or vomiting, inability to tolerate a solid or semi-solid oral diet, abdominal distension, absence of flatus and stool, radiological evidence of ileus.
  • Levels of serum inflammatory markers (in pg/mL) [ Time Frame: Inflammatory markers will be collected preoperatively, day 1 and 3 postoperatively. Blood samples will be stored after collection for later testing (up to 1 year). ]
    Markers to be tested: CRP, Procalcitonin, IL6, IL12
  • Length of postoperative stay (in days) [ Time Frame: From date of surgery until discharge from hospital (14 days on average) ]
Current Other Pre-specified Outcome Measures
 (submitted: October 25, 2016)
Rate of gastric emptying using the 13-carbon octanoate breath test [ Time Frame: This test will be undertaken on day 2 postoperatively, and will take approximately 4 hours ]
A subgroup of 40 patients will be investigated for this study
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Prucalopride in Postoperative Ileus
Official Title  ICMJE A Randomized Double-blind Placebo Controlled Trial of Prucalopride to Reduce the Duration of Postoperative Ileus in Patients Undergoing Elective Colorectal Surgery
Brief Summary

Postoperative ileus (POI) refers to the period of gut dysmotility that occurs after abdominal surgery. Patients with POI are unable to eat, suffer ongoing nausea and vomiting, are unable to open their bowels and have a prolonged hospital stay. Research at ADHB shows that 25% of patients will have a prolonged POI after elective bowel resection, which makes it the most common major complication after colorectal surgery. Clinicians currently lack a definitive medication to prevent or treat POI, which means POI causes patients ongoing morbidity and places a significant drain on healthcare resources. Serotonin plays an important role in gut motility. Evidence suggests that serotonin agonists, such as prucalopride, increase gut transit and may have anti-inflammatory properties. The hypothesis of this study is that Prucalopride given pre-operatively and continued post-operatively in patients having an elective bowel resection will improve gut function recovery after surgery and reduce POI.

The investigators' proposed study is a double-blinded randomised controlled trial of prucalopride compared to an identical placebo tablet, in patients having an elective bowel resection at Auckland City Hospital. Patients will receive a single tablet of Prucalopride or placebo 2-3 hours preoperatively and then daily after operation for a maximum of 6 days. The primary endpoint will be return to bowel function defined by the time to tolerate a solid diet and pass stool. In addition, the investigators plan to assess postoperative gastric emptying rates using the safe and non-invasive carbon breath test method. This will allow the investigators to determine the effects of prucalopride on the stomach, and support its role as a gastric prokinetic.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Postoperative Ileus
  • Colorectal Surgery
  • Postoperative Complications
Intervention  ICMJE
  • Drug: Prucalopride
    Prucalopride 2mg capsule
    Other Names:
    • Resolor
    • Resotrans
  • Drug: Placebo Oral Capsule
    Placebo capsule
Study Arms  ICMJE
  • Experimental: Intervention group
    Patients will receive an oral capsule containing 2mg Prucalopride 2-3 hours preoperatively. Study medication (2mg oral Prucalopride daily) will continue for 6 days postoperatively or until the patient has achieved the study's primary outcome.
    Intervention: Drug: Prucalopride
  • Placebo Comparator: Placebo group
    Patients will receive an oral capsule containing a placebo 2-3 hours preoperatively. Study medication (placebo) will continue for 6 days preoperatively or until the patient has achieved the study's primary outcome.
    Intervention: Drug: Placebo Oral Capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 25, 2017)
150
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2016)
140
Estimated Study Completion Date  ICMJE February 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients from Auckland District Health Board catchment
  • Age 18 or older
  • Elective and subacute surgery
  • Right hemicolectomy, left hemicolectomy, sigmoid colectomy, anterior resection, Hartmann's procedure, subtotal colectomy
  • Operation with or without the formation of a colostomy
  • Indication for operation: colon cancer, diverticular disease, gynaecological
  • Able to understand risks and benefits of the study
  • Able to give informed consent

Exclusion Criteria:

  • ASA 4 or greater
  • Allergy to any serotonin medication
  • Active inflammatory bowel disease
  • Planned formation of an ileostomy during surgery
  • Moderate to severe renal impairment (Creatinine clearance<50mL/min/1.73m2)
  • Severe hepatic impairment (Child-Pugh C)
  • Pregnancy
  • Pre-existing gut dysmotility disorder including endocrine, metabolic or neurological cause
  • Pre-operative malnutrition requiring parenteral nutrition
  • Inability to give consent or participate in post-operative assessments due to dementia, cognitive impairment, language difficulties, delirium
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02947269
Other Study ID Numbers  ICMJE UOA-prucRCT1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party A/Prof Ian Bissett, University of Auckland, New Zealand
Study Sponsor  ICMJE University of Auckland, New Zealand
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Auckland, New Zealand
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP