Retrograde and Antegrade Enema for Prevention of LARS After LAR: a Randomized Controlled Trial

Официальное название

Retrograde and Antegrade Enema for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if enema works to prevent low anterior resection syndrome (LARS) in adults. The main questions it aims to answer are: 1. To describe the level of stoma adaptation before and after the patients received enemas during the stoma period as well as the levels and trends of LARS, bowel function, sleep quality, and quality of life after stoma reduction surgery 2. To compare the effects and advantages and disadvantages of antegrade and retrograde enema, and to investigate whether these two types of enema can provide safe and effective preventive measures for the prevention of LARS, the improvement of bowel function, and the enhancement of sleep and quality of life in rectal cancer patients after low anterior resection. Researchers will compare antegrade enema, retrograde enema, and the standard of care to see if these two types of enema work to prevent LARS. Participants will: 1. Receive either antegrade or retrograde enema or no enema based on the standard of care at 1 month after anterior rectal resection, until the ileostomy reversal. 2. Keep a diary of their symptoms.

Вмешательства

• Другое transanal irrigation
  The enema is administered retrogradely via the anus. The enema commences one month post-operatively for patients with well-healed wounds, absence of stoma-related complications, and no evidence of anastomotic leakage upon digital examination, until ileostomy reversal. the catheter is gently and slowly inserted 7-10 cm through the anus. The initial irrigation volume is set at 500 ml and is gradually increased based on the patient's tolerance, up to a maximum of 1000 ml. 39-41°C warm water is the
• Другое antegrade enema
  The enema is administered through the distal end of the ileocecal stoma, directed towards the anus. The enema commences one month post-operatively for patients with well-healed wounds, absence of stoma-related complications, and no evidence of anastomotic leakage upon digital examination, until ileostomy reversal. Using a disposable catheter, insert it about 20 cm. The initial irrigation volume is set at 500 ml and is gradually increased based on the patient's tolerance, up to a maximum of 1000

Первичные конечные точки

• low anterior resection syndrome score (LARS score) [Срок оценки: Pre-discharge, 1 month, 2 months, 3 months, 6 months after ileostomy reversal]

Вторичные конечные точки (3)

• bowel function [Срок оценки: before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal]
• quality of life for rectal cancer patients [Срок оценки: before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal]
• quality of sleep [Срок оценки: before anterior rectal resection, before starting enemas 1 month postoperatively, 2 months, 3-4 months postoperatively; 1 month, 2 months, 3 months, 6 months after stoma reduction]

Критерии участия

Критерии включения

• Based on the NCCN guidelines for the pathological diagnosis of rectal cancer, patients are identified as having Primary Rectal Adenocarcinoma.
• ≥18 years.
• For the first time, anterior rectal dissection combined with prophylactic ileostomy was performed using laparoscopic, robotic, and open techniques.
• The patient exhibits normal cognitive and expressive abilities.
• Informed consent was obtained for voluntary participation in the study.

Критерии исключения

• American Society of Anesthesiologists (ASA) Class III or higher.
• A combination of other intestinal conditions, including inflammatory bowel disease and Crohn's disease.
• Mental disorders and prolonged use of psychotropic medications.
• The presence of contraindications to enema administration.

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

Профилактика

Центры проведения

Китай · 1 центр

• Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan — Chengdu, Sichuan

Идентификаторы

NCT: NCT06717854 · SCCHEC-02-2024-226

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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