NCT06633133 Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision
| NCT ID | NCT06633133 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 620 participants |
| Start Date | 2024-10-10 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 620 participants in total. It began in 2024-10-10 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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
Contact & Investigator
fan li
STUDY CHAIR
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Frequently Asked Questions
Who can join the NCT06633133 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06633133 currently recruiting?
Yes, NCT06633133 is actively recruiting participants. Contact the research team at levinecq@163.com for enrollment information.
Where is the NCT06633133 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT06633133 clinical trial?
NCT06633133 is sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. The principal investigator is fan li at Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. The trial plans to enroll 620 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.