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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
Prucalopride 2mg capsule
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
- 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.
- 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) ]
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947269
|Contact: Ian P Bissett, MD, FRACS||+649 373 7599 ext firstname.lastname@example.org|
|University of Auckland||Recruiting|
|Auckland, New Zealand, 1023|
|Contact: Ian Bissett, MD, FRACS +649 3737599 ext 89821 email@example.com|