Antegrade Intestinal Fluid Reinfusion Verse Water Infusion Through Prophylactic Ileal Stoma for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- LARS score(m1)
研究概览
简要总结
The goal of this clinical trial is to learn if antegrade intestinal fluid reinfusion works to prevent low anterior resection syndrome (LARS) in patients with prophylactic ileal stoma. The main questions it aims to answer are:
- Does it work to prevent LARS by antegrade intestinal fluid reinfusion before performing the ileostomy reversal surgery?
- Is antegrade intestinal fluid reinfusion more effective than water infusion in preventing LARS.
Participants will:
- Receive either antegrade intestinal fluid reinfusion or antegrade water infusion through ileal stoma 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mid to low rectal cancer (within 10cm of the anal verge) who undergo radical DIXON+ileostomy surgery.
- •General situation is well and one can take care of themselves.
- •Anal digital examination confirms that the anastomotic site has fully healed 1 month after surgery.
- •The anal sphincter function is good, and the ilestomy reverse surgery has not been completed.
- •Regardless of whether preoperative radiotherapy or chemotherapy has been received.
排除标准
- •Patients with anastomotic leakage after rectal cancer surgery.
- •The patient's general physical condition is poor and they are unable to take care of themselves.
- •Expected inability to retract the stoma.
- •Patients with preoperative inflammatory bowel disease, such as ulcerative colitis, Crohn's disease, etc.
- •inability to treat according to the plan, poor compliance.
研究组 & 干预措施
Intestinal fluid reinfusion
Starting from 4 weeks after the DIXON + ileostomy surgery until the day before the ileostomy reversal surgery, the patient was instructed on enema procedures by enterostomal therapist after being enrolled in the study.
After preparing the autologous intestinal fluid, it is diluted with warm saline to a volume of 200-500 ml. It is then returned through the distal end of the ileal stoma in a retrograde manner, once every other day.
干预措施: intestinal fluid infusion (Combination Product)
Water infusion
Starting from 4 weeks after the DIXON + ileostomy surgery until the day before the ileostomy reversal surgery, the patient was instructed on enema procedures by enterostomal therapist after being enrolled in the study.
Prepare 200-500 ml of potable water, and then infuse it antegradely from the distal end of the ileal stoma, once every other day.
干预措施: potable water (Combination Product)
结局指标
主要结局
LARS score(m1)
时间窗: 1 month after ileostomy reversal surgery
Improvement in LARS score 1 month after ileostomy reversal surgery between the two group. Low Anterior Resection Syndrome Score (LARS Score) is a validated specific score for low anterior resection syndrome which ranges from 0 points (normal - best score) to 42 point (LARS major - worst score).
次要结局
- Major LARS rate(m1)(1 month after ileostomy reversal)
- LARS score (m0-12)(2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery)
- MSKCC BFI(2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery)
- Wexner score(2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery)
- quality of life for rectal cancer patients(2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery)
研究者
Pei-Rong Ding
Professor
Sun Yat-sen University