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NCT Number: NCT02947269

Prucalopride in Postoperative Ileus

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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Key information

Conditions

Postoperative Ileus Colorectal Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Auckland

Auckland, 1023, New Zealand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prucalopride

Drug

Prucalopride 2mg capsule

Other names: Resolor, Resotrans

Placebo oral capsule

Drug

Placebo capsule

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Auckland, New Zealand

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 27, 2016
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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