NCT06717854尚未招募不适用
Retrograde and Antegrade Enema for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial
Sichuan Cancer Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年3月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- low anterior resection syndrome score (LARS score)
研究概览
简要总结
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:
- 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
- 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:
- 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.
- Keep a diary of their symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
low anterior resection syndrome score (LARS score)
时间窗: Pre-discharge, 1 month, 2 months, 3 months, 6 months after ileostomy reversal
次要结局
- bowel function(before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal)
- quality of life for rectal cancer patients(before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal)
- quality of sleep(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)
研究者
Hui Yang
Principal Investigator
Sichuan Cancer Hospital and Research Institute
研究点 (1)
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