Low-Residue Diet Versus Rectal Enema Before Laparoscopic Surgery for Endometrial Cancer

Официальное название

Low-Residue Diet Versus Rectal Enema Before Laparoscopic Endometrial Cancer Surgery: A Prospective Randomized Controlled Trial

Обзор

The goal of this clinical trial is to compare a standardized 3-day bowel preparation protocol with a rectal enema before laparoscopic surgery for endometrial cancer. The study will evaluate whether the dietary bowel preparation protocol can be used instead of a rectal enema while maintaining an adequate surgical view during surgery. The main questions it aims to answer are: * Can the dietary bowel preparation protocol provide surgical exposure comparable to a rectal enema? * Can the dietary bowel preparation protocol reduce the minimum Trendelenburg position and pneumoperitoneum pressure required to obtain an adequate surgical view? * Does either bowel preparation method cause more discomfort or side effects before surgery? Researchers will compare a standardized 3-day bowel preparation protocol with a rectal enema before surgery. Participants will: * Be randomly assigned to receive either a standardized 3-day bowel preparation protocol or a rectal enema before surgery. * Undergo standard laparoscopic surgery for endometrial cancer. * Have surgical exposure, the minimum Trendelenburg position, the minimum pneumoperitoneum pressure, operative outcomes, postoperative recovery, and bowel preparation-related symptoms and discomfort assessed as part of routine clinical care.

Подробное описание

Adequate bowel preparation is important for achieving optimal surgical exposure during laparoscopic surgery for endometrial cancer. Inadequate bowel preparation may impair visualization of the operative field, requiring steeper Trendelenburg positioning and higher pneumoperitoneum pressures, which may increase the physiological burden of surgery and affect operative performance.

Mechanical bowel preparation with rectal enema is commonly used before gynecologic surgery, although its routine use remains controversial because evidence supporting its clinical benefit is limited. A standardized 3-day bowel preparation protocol may improve patient tolerance while maintaining adequate surgical conditions. However, prospective randomized studies comparing these two approaches specifically in laparoscopic endometrial cancer surgery remain limited.

This prospective randomized controlled trial will compare a standardized 3-day bowel preparation protocol with a preoperative rectal enema before laparoscopic surgery for endometrial cancer. The primary objective is to determine whether the dietary bowel preparation protocol can provide surgical conditions comparable to those achieved with rectal enema.

In addition to subjective assessment of surgical exposure, the study will evaluate objective intraoperative parameters, including the minimum Trendelenburg position and the minimum pneumoperitoneum pressure required to maintain an adequate surgical view. Operative outcomes, postoperative recovery, patient tolerance of the bowel preparation methods, and bowel preparation-related symptoms will also be evaluated.

The findings of this study may help optimize preoperative bowel preparation strategies, reduce unnecessary patient burden, and support evidence-based perioperative care for patients undergoing laparoscopic surgery for endometrial cancer.

Вмешательства

• Поведенческое Low-Residue Diet
  Participants will follow a standardized 3-day bowel preparation protocol consisting of a low-residue diet on day 3 before surgery, a soft or pureed diet on day 2, and a clear liquid diet on the day before surgery, with adequate hydration throughout the preparation period.
• Препарат Sodium Phosphate Rectal Enema
  Participants will receive a single sodium phosphate rectal enema approximately 12 hours before surgery according to the manufacturer's instructions and the institutional bowel preparation protocol.

Первичные конечные точки

• Intraoperative Visual Index Score [Срок оценки: Intraoperatively, after pneumoperitoneum establishment and placement of the camera trocar and one lateral ancillary trocar]
• Minimum Trendelenburg Position Required for Adequate Surgical Exposure [Срок оценки: Intraoperatively]
• Minimum Pneumoperitoneum Pressure Required for Adequate Surgical Exposure [Срок оценки: Intraoperatively]

Вторичные конечные точки (4)

• Operative Time [Срок оценки: During surgery]
• Length of Hospital Stay [Срок оценки: At hospital discharge, assessed up to 30 days after surgery]
• Time to First Flatus [Срок оценки: From completion of surgery until the first documented passage of flatus, assessed up to 7 postoperative days]
• Patient Tolerance of Bowel Preparation [Срок оценки: From preoperative bowel preparation until postoperative day 1]

Критерии участия

Критерии включения

• Female participants aged 18 to 90 years.
• Scheduled to undergo elective laparoscopic surgery for endometrial cancer.
• Willing and able to provide written informed consent.

Критерии исключения

• Planned open (abdominal) surgery.
• Known allergy or contraindication to sodium phosphate rectal enema.
• Age over 90 years.
• Refusal or inability to provide written informed consent.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Başakşehir Çam and Sakura City Hospital — Istanbul

Идентификаторы

NCT: NCT07702799 · ENDO-DIET-RCT-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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