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Prucalopride in Postoperative Ileus

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ClinicalTrials.gov Identifier: NCT02947269
Recruitment Status : 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

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.


Condition or disease Intervention/treatment Phase
Postoperative Ileus Colorectal Surgery Postoperative Complications Drug: Prucalopride Drug: Placebo Oral Capsule Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Double-blind Placebo Controlled Trial of Prucalopride to Reduce the Duration of Postoperative Ileus in Patients Undergoing Elective Colorectal Surgery
Actual Study Start Date : October 25, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
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.
Drug: Prucalopride
Prucalopride 2mg capsule
Other Names:
  • Resolor
  • Resotrans

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.
Drug: Placebo Oral Capsule
Placebo capsule




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time until passage of stool (in days) [ Time Frame: From date of surgery until discharge from hospital (14 days on average) ]
  2. Time until passage of flatus (in days) [ Time Frame: From date of surgery until discharge from hospital (14 days on average) ]
  3. Time until tolerance of solid oral diet (in days) [ Time Frame: From date of surgery until discharge from hospital (14 days on average) ]
  4. 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.

  5. 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

  6. Length of postoperative stay (in days) [ Time Frame: From date of surgery until discharge from hospital (14 days on average) ]

Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947269


Contacts
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Contact: Ian P Bissett, MD, FRACS +649 373 7599 ext 89821 i.bissett@auckland.ac.nz

Locations
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New Zealand
University of Auckland Recruiting
Auckland, New Zealand, 1023
Contact: Ian Bissett, MD, FRACS    +649 3737599 ext 89821    i.bissett@auckland.ac.nz   
Sponsors and Collaborators
University of Auckland, New Zealand

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Responsible Party: A/Prof Ian Bissett, Professor Ian Bissett, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT02947269     History of Changes
Other Study ID Numbers: UOA-prucRCT1
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ileus
Postoperative Complications
Pathologic Processes
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Prucalopride
Laxatives
Gastrointestinal Agents
Serotonin 5-HT4 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs