Impact of Varying Doses of Prucalopride on Improving Gut Function Recovery After Elective Colorectal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prucalopride 2mg, Prucalopride 4mg, Standard Care.
- Who it may be relevant to
- Registry conditions: Post-Op Complication. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Different Doses of Prucalopride on Improving Gut Function Recovery Following Elective Colorectal Surgery: a Randomized, Double-blind Study
Overview
Postoperative ileus (POI) is a common complication after abdominal surgery, causing symptoms like nausea, vomiting, abdominal distension, and delayed passage of flatus and stool. Management remains challenging, with limited pharmacological options available. Prucalopride, a selective serotonin 5-HT4 receptor agonist, has shown promise in accelerating gastrointestinal recovery after surgery. However, the optimal timing and dosing for preventing POI remains unclear. Higher doses may provide more potent prokinetic effects in the postoperative setting. his study investigates if higher doses of prucalopride (4 mg) improve bowel function return and hospital stay in elective colorectal surgery patients compared to standard doses and placebo.
Detailed description
Postoperative ileus (POI) is a common complication after abdominal surgery, particularly colorectal procedures, which can delay recovery and prolong hospital stay. POI is characterized by a transient cessation of coordinated bowel motility, leading to symptoms such as nausea, vomiting, abdominal distension, and delayed passage of flatus and stool. Effective management of POI remains challenging, with limited pharmacological options available. Prucalopride, a highly selective serotonin 5-HT4 receptor agonist, has shown promise in accelerating gastrointestinal recovery after surgery. However, the optimal timing and dosing of prucalopride for preventing POI remains unclear. Studies have shown dose-dependent improvements in outcomes with doses up to 4 mg daily. Higher doses may provide more potent prokinetic effects in the postoperative setting, but no studies have examined doses above 2 mg for prevention of POI in colorectal surgery. The purpose of this study is to determine if higher doses of prucalopride (4 mg) result in faster return of bowel function and shorter hospital stay compared to the standard dose (2 mg) and placebo in patients undergoing elective colorectal surgery.
Interventions
- Drug Prucalopride 2mg
Prucalopride 2mg taken preoperatively - Drug Prucalopride 4mg
Prucalopride 4mg taken preoperatively - Other Standard Care
Standard Supportive care
Primary outcome measures
- time to first stool [Time frame: 7 days]
- time to tolerance of food [Time frame: 7 days]
Secondary outcome measures (2)
- time to first flatus [Time frame: 7 days]
- incidence of prolonged postoperative ileus [Time frame: 7 days]
Eligibility criteria
Inclusion criteria
- undergoing elective colorectal surgery, including but not limited to colectomy, rectal resection, and sigmoid resection.
Exclusion criteria
- Emergency surgery
- Total colectomy
- Creation of a stoma
- Pre-existing gastrointestinal disorders
- Severe renal or hepatic impairment
- Known hypersensitivity to prucalopride.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
Egypt · 1 center
- Matareya Hospital — Cairo
Identifiers
NCT: NCT06816407 · HM000186