NCT06633133招募中不适用
Comparing the Safety and Efficacy of Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision for Rectal Cancer: a Multicentre, Prospective, Open-label, Blinded Endpoint, PROBE Study
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University1 个研究点 分布在 1 个国家目标入组 620 人开始时间: 2024年10月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 620
- 试验地点
- 1
- 主要终点
- Comprehensive Complication index (CCI) at the 6th postoperative month
研究概览
简要总结
The goal of this clinical trial is to learn to compare the safety and efficacy of virtual ileostomy versus diverting ileostomy in patients undergoing sphincter-saving surgery for rectal cancer. The main questions it aims to answer are:
- Is the virtual ileostomy a safe and effective alternative to the ileostomy?
- Is it scientifically reasonable to perform diverting ileostomy intraoperatively? Researchers will compare virtual ileostomy to diverting ileostomy to see if the virtual ileostomy works to reduce rates of stoma.
Participants will:
- Performing diverting ileostomy or virtual ileostomy undergoing sphincter-saving surgery for rectal cancer
- Continuous follow-up of their complications after the first surgery
详细描述
This study is a national multicenter, large-sample, randomized controlled study
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of rectal cancer confirmed by pathology
- •Age ≥ 18 years
- •Total mesorectal excision (TME) surgical procedures and colon-rectum or colon-anal anastomosis：1.anterior resection (AR/ PME),
- •low anterior resection (LAR) , 3.intersphincteric abdominoperineal resection (ISR), 4.transanal total mesorectal excision (TaTME)
- •Signed informed consent
- •Ability to understand the nature and risks of participating in the trial
排除标准
- •Emergency surgery, open surgery
- •ASA score >3points
- •Patients with combined complete intestinal obstruction
- •Long-term history of using immunosuppressants or glucocorticoids
- •Combined severe cardiac disease: with congestive heart failure or NYHA cardiac function ≥ grade
- •Patients with a history of myocardial infarction or coronary artery surgery within 6 months before the procedure
- •Chronic renal failure (requiring dialysis or glomerular filtration rate <30 mL/min)
- •Intraoperative combined multi-organ resection
- •Combined cirrhosis of the liver
- •Intraoperative findings of incomplete anastomosis and positive insufflation test
- •Modified Bacon procedure(Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis)
- •Due to an intraoperative accident the surgeon felt that a diverting ileostomy was necessary.
- •Currently participating in other clinical trials
结局指标
主要结局
Comprehensive Complication index (CCI) at the 6th postoperative month
时间窗: An average of 6 month from the date of low anterior resection for rectal cancer until the date of when the patient's condition is stabilized without complications
The Comprehensive Complication Index (CCI)summarises all postoperative complications based on the established Clavien-Dindo classification (ranging from mild complications not leading to a deviation from the normal clinical course (grade I) up to postoperative death (grade V)) at an individual patient level according to their grade of severity.
次要结局
- Comprehensive Complication Index (CCI) at the first postoperative, 3 months postoperative, 1 year postoperative,3 years postoperative,5 years postoperative(5 year)
- First postoperative complications(From the date of randomization until the date of discharge, an average of 7 to 14 days)
- Stoma-related complications(Through study completion, an average of 5 year)
- Complications after ileostomy closure(Through study completion, an average of 5 year)
- Postoperative hospitalization days(Initial and all subsequent hospitalizations)(Through study completion, an average of 5 year)
- Virtual ileostomy remove time(days)(During hospitalization,approximately 14 days)
- The number of hospitalizations(Initial and all subsequent hospitalizations)(Through study completion, an average of 5 year)
- Duration of bearing the stoma (months)(Through study completion, an average of 5 year)
- Total hospitalization costs(Initial and all subsequent hospitalizations)(Through study completion, an average of 5 year)
- Number of participants with terminal ostomy(Through study completion, an average of 5 year)
- Number of Participants with unscheduled secondary surgery(Through study completion, an average of 5 year)
- The rate at which virtual ileostomy was converted to diverting ileostomy(Through study completion, an average of 5 year)
- Bile acid concentration of drainage fluid(During hospitalization,approximately 7 days)
- Number of participants with stoma (terminal/loop) at 6 months after initial surgery(6 months from the date of first surgery for rectal cancer)
- Interventional drainage rate(Through study completion, an average of 5 year)
- Fecal Incontinence Scale(Wexner Score)(Through study completion, an average of 5 year)
- Quality of life(EORTC QLQ-C30)(Through study completion, an average of 5 year)
- Disease free survival (DFS)(Through study completion, an average of 5 year)
- Overall survival (OS)(Through study completion, an average of 5 year)
- Rate of permanent ileostomy(From the date of first surgery,an average of 3 year)
- Completion of intended perioperative or adjuvant chemotherapy(Through study completion, an average of 5 year)
- Low anterior resection syndrome for rectal cancer(Through study completion, an average of 5 year)
- Quality of life for fecal incontinence(Through study completion, an average of 5 year)
- Permanent ileostomy rate(3 years from the date of first surgery for rectal cancer)
- Mortality(30 days from the date of first surgery for rectal cancer)
研究者
研究点 (1)
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