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 |
Trial Parameters
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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
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