|

Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision

RECRUITINGN/ASponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Actively Recruiting
PhaseN/A
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University
Started2024-10-10
Est. completion2026-12-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06633133

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerRectal Cancer

Browse More Trials

Cancer trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.