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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
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| Placebo group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prucalopride | Drug | Prucalopride 2mg capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Time until recovery of gastrointestinal function | 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. | From date of surgery until discharge from hospital (14 days on average) |
| Measure | Description | Time Frame |
|---|---|---|
| Time until passage of stool (in days) | From date of surgery until discharge from hospital (14 days on average) | |
| Time until passage of flatus (in days) | From date of surgery until discharge from hospital (14 days on average) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of gastric emptying using the 13-carbon octanoate breath test | A subgroup of 40 patients will be investigated for this study | This test will be undertaken on day 2 postoperatively, and will take approximately 4 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Auckland | Auckland | 1023 | New Zealand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35639621 | Derived | Milne T, Liu C, O'Grady G, Woodfield J, Bissett I. Effect of prucalopride to improve time to gut function recovery following elective colorectal surgery: randomized clinical trial. Br J Surg. 2022 Jul 15;109(8):704-710. doi: 10.1093/bjs/znac121. |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C406662 | prucalopride |
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| Placebo Oral Capsule | Drug | Placebo capsule |
|
| Time until tolerance of solid oral diet (in days) | From date of surgery until discharge from hospital (14 days on average) |
| Presence of prolonged postoperative ileus | 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. | From date of surgery until discharge from hospital (14 days on average) |
| Levels of serum inflammatory markers (in pg/mL) | Markers to be tested: CRP, IL1beta, IL6, IL8, IL12, TNFalpha | 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). |
| Length of postoperative stay (in days) | From date of surgery until discharge from hospital (14 days on average) |