NCT05001763

Prucalopride for Postoperative Ileus in Patients Undergoing Robot-assisted Laparoscopic Radical Cystectomy

A Randomized Controlled Clinical Trial of Prucaloprude Succinate in Promoting the Recovery of Intestinal Function After Robot-assisted Laparoscopic Radical Cystectomy and Urinary Diversion

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The first purpose is to determine whether prucalopride can promote the recovery of intestinal function after robot-assisted laparoscopic radical cystectomy and urinary diversion. The secondary objectives is to speed up postoperative ventilation, defecation, reduce the time of first solid food tolerance, reduce postoperative hospital stay, reduce the incidence of readmission due to intestinal obstruction and the incidence of complications within 180 days.

Detailed description

The incidence of bladder cancer is getting higher and higher. 30% of them are myometrial invasive bladder cancer, which requires radical cystectomy. This operation is more traumatic, because it involves many physiological structures, and there will be many postoperative complications, of which intestinal complications are the most common. The main manifestation is postoperative ileus (POI). At present, one is chewing gum after surgery, and the other is the Avimopan, which is recognized as the method to promote intestinal recovery after operation. Avimopan is a peripheral μ-opioid receptor antagonist, which can improve intestinal dysfunction. Because Avimopan has not been widely used in China, its clinical application is limited. It is reported that prucalopride may be one of the methods to promote the recovery of intestinal motility after operation. Prucalopride, an alternative to benzamide, has selective 5-HT4 agonist activity and has previously been shown to significantly improve intestinal motility and transport. The drug was well tolerated and there was no obvious adverse reaction. In addition, prucalopride has been approved in Europe and America for symptomatic treatment of chronic constipation in women whose laxatives do not provide adequate relief. However, its perioperative use in radical cystectomy has not been tested. This study will test the ability and safety of prucalopride to promote the recovery of postoperative intestinal function 2 days before radical cystectomy.

Conditions

• Postoperative Ileus
• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Prucalopride	Prucalopride, 2mg, tablet. First given 2 days before surgery beginning on POD 1, until defecation or for a maximum of 7 days of postoperative treatment
DRUG	Placebo	Glucose, 2mg, tablet.

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-09-01
• Completion: 2023-10-01
• First posted: 2021-08-12
• Last updated: 2021-08-12