Impact of Varying Doses of Prucalopride on Improving Gut Function Recovery After Elective Colorectal Surgery

Future University in Egypt

Status and phase: Enrolling; Phase 3

Conditions: Post-Op Complication

Treatments: Other: Standard Care; Drug: Prucalopride 4mg; Drug: Prucalopride 2mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06816407

HM000186

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

180 participants in 3 patient groups, including a placebo group

Control arm

Placebo Comparator group

Description:

Standard care

Treatment:

Other: Standard Care

Prucalopride 2mg

Experimental group

Description:

Prucalopride 2mg

Treatment:

Drug: Prucalopride 2mg

Other: Standard Care

Prucalopride 4mg

Experimental group

Description:

Prucalopride 4mg

Treatment:

Drug: Prucalopride 4mg

Other: Standard Care