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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
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
Glucose, 2mg, tablet.
Time to defaecation, measured in hours, from the time the surgery ends till the first observed
Time frame: up to 30 days after surgery
Postoperative first passing flatus reported by the patients
Time frame: up to 30 days after surgery
First solid food tolerance time
Time frame: up to 30 days after surgery
Postoperative C-reactive protein(CRP)
Time frame: postoperative day 1 and 3
Length of postoperative hospital stay (LOS)(days)
Time frame: 30 days or until hospital discharge whichever occurs first
Incidence of readmission within 180 days
Time frame: up to 180 days after surgery
Incidence of complications defined according to the Clavien-Dindo Classification within 180 days
Time frame: up to 180 days after surgery
Incidence of adverse events related to drug usage
include Diarrhoea, Flatulence, Nausea, Abdominal pain, Headaches, Menstrual disorder, Dizziness, Skeletal pain, ECG nodal arrhythmia
Time frame: up to 7 days after drug usage
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.