Prucalopride in Postoperative Ileus

Postoperative Complications Clinical Trial

Official title:

A Randomized Double-blind Placebo Controlled Trial of Prucalopride to Reduce the Duration of Postoperative Ileus in Patients Undergoing Elective Colorectal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02947269
• Other study ID #: UOA-prucRCT1
• Status: Completed
• Phase: Phase 3
• Start date: October 25, 2017
• Est. completion date: August 30, 2020

Study information

• Verified date: September 2021
• Source: University of Auckland, New Zealand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Surgery
• Ileus
• Postoperative Complications
• Postoperative Ileus

Intervention

Drug:
• Prucalopride
Prucalopride 2mg capsule
• Placebo Oral Capsule
Placebo capsule

Locations

Country	Name	City	State
New Zealand	University of Auckland	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
University of Auckland, New Zealand

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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)
Secondary	Time until passage of stool (in days)		From date of surgery until discharge from hospital (14 days on average)
Secondary	Time until passage of flatus (in days)		From date of surgery until discharge from hospital (14 days on average)
Secondary	Time until tolerance of solid oral diet (in days)		From date of surgery until discharge from hospital (14 days on average)
Secondary	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)
Secondary	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).
Secondary	Length of postoperative stay (in days)		From date of surgery until discharge from hospital (14 days on average)