Prucalopride in Postoperative Ileus

NCT ID: NCT02947269

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-25
• Study Completion Date: 2020-08-30

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.

Conditions

Postoperative Ileus; Colorectal Surgery; Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Prucalopride

Intervention Type: DRUG

Prucalopride 2mg capsule

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.

Group Type: PLACEBO_COMPARATOR

Placebo Oral Capsule

Intervention Type: DRUG

Placebo capsule

Interventions

Prucalopride

Prucalopride 2mg capsule

Intervention Type: DRUG

Placebo Oral Capsule

Placebo capsule

Intervention Type: DRUG

Other Intervention Names

Resolor; Resotrans

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Auckland, New Zealand

OTHER

Sponsor Role: lead

Responsible Party

A/Prof Ian Bissett

Professor Ian Bissett

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Auckland

Auckland, , New Zealand

Countries

New Zealand

References

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.

Reference Type: DERIVED

PMID: 35639621 (View on PubMed)

Other Identifiers

UOA-prucRCT1

Identifier Type: -

Identifier Source: org_study_id