Overview
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
Description
This study is a national multicenter, large-sample, randomized controlled study
Eligibility
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