Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision

Army Medical University of People's Liberation Army

Status: Enrolling

Conditions: Rectal Cancer

Treatments: Procedure: Virtual ileostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06633133

VIRTUAL 01

Details and patient eligibility

About

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

Full description

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

Enrollment: 620 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

620 participants in 2 patient groups

Virtual ileostomy

Experimental group

Description:

A pre-stage ileostomy, anchored under the abdominal wall by a vascular sling or rubber tape through the mesenteric window, is delivered to the outside of the abdomen, where the VI is pulled through the abdominal wall.

Treatment:

Procedure: Virtual ileostomy

Diverting ileostomy

No Intervention group

Description:

Diverting ileostomy (DI) is a common fecal diversion procedure performed in patients undergoing total mesorectal excision (TME) procedure for rectal cancer to protect the anastomosis and reduce the risk of complications.