NCT06633133Recruiting
Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision
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
Source: ClinicalTrials.gov · Last updated 16 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 620 (estimated)
- First submitted
- 29 Sept 2024
- Start date
- 10 Oct 2024
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Diseases
- Colorectal cancer
- NCT number
- NCT06633133
What you commit to
- Study type: Interventional
- Planned participants: 620
- From 10 Oct 2024 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency surgery, open surgery
- 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
- Intraoperative combined multi-organ resection
Other illness
- Long-term history of using immunosuppressants or glucocorticoids
- Chronic renal failure (requiring dialysis or glomerular filtration rate \<30 mL/min)
Other
- ASA score \>3points
- Patients with combined complete intestinal obstruction
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Daping Hospital, Third Military Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.