RecruitingNot Applicable

Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision

China620 participantsStarted 2024-10-10

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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), 2. 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 Exclusion Criteria: * 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 2. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comprehensive Complication index (CCI) at the 6th postoperative month

Timeframe: 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

Trial details

NCT IDNCT06633133

SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

fan li, PhD

18696539200 levinecq@163.com

View on ClinicalTrials.gov More Rectal Cancer trials