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

Официальное название

The Effect of Different Doses of Prucalopride on Improving Gut Function Recovery Following Elective Colorectal Surgery: a Randomized, Double-blind Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Prucalopride 2mg
  Prucalopride 2mg taken preoperatively
• Препарат Prucalopride 4mg
  Prucalopride 4mg taken preoperatively
• Другое Standard Care
  Standard Supportive care

Первичные конечные точки

• time to first stool [Срок оценки: 7 days]
• time to tolerance of food [Срок оценки: 7 days]

Вторичные конечные точки (2)

• time to first flatus [Срок оценки: 7 days]
• incidence of prolonged postoperative ileus [Срок оценки: 7 days]

Критерии участия

Критерии включения

• undergoing elective colorectal surgery, including but not limited to colectomy, rectal resection, and sigmoid resection.

Критерии исключения

• Emergency surgery
• Total colectomy
• Creation of a stoma
• Pre-existing gastrointestinal disorders
• Severe renal or hepatic impairment
• Known hypersensitivity to prucalopride.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Египет · 1 центр

• Matareya Hospital — Cairo

Идентификаторы

NCT: NCT06816407 · HM000186

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗