Comparing virtual ileostomy and diverting ileostomy for rectal cancer surgery

Comparing the Safety and Efficacy of Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision for Rectal Cancer: a Multicentre, Prospective, Open-label, Blinded Endpoint, PROBE Study

This study is testing whether a new type of ileostomy can lower the need for stomas in patients having surgery for rectal cancer compared to the traditional method.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 620 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (other)
• Locations: 1 site (Chongqing)
• Trial ID: NCT06633133 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the safety and efficacy of virtual ileostomy versus diverting ileostomy in patients undergoing sphincter-saving surgery for rectal cancer. It is a national multicenter, randomized controlled study that will evaluate whether virtual ileostomy can effectively reduce stoma rates compared to traditional diverting ileostomy. Participants will undergo either procedure and will be followed for complications post-surgery. The study seeks to determine if virtual ileostomy is a viable alternative during total mesorectal excision.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with rectal cancer who are undergoing specific surgical procedures like anterior resection or low anterior resection.

Not a fit: Patients requiring emergency surgery, those with severe comorbidities, or those with certain contraindications will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective surgical option for patients with rectal cancer, potentially reducing the need for permanent stomas.

How similar studies have performed: While the concept of virtual ileostomy is innovative, similar studies have not been widely conducted, making this approach relatively novel.

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

Where this trial is running

Chongqing

• Daping Hospital, Third Military Medical University — Chongqing, China (RECRUITING)

Study contacts

• Study coordinator: fan li, PhD

Conditions: Rectal Cancer, virtual ileostomy, diverting ileostomy