Clinical trial NCT06633133: Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Cancer
Keywords: virtual ileostomy
diverting ileostomy
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

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

Primary outcomes:
measure: Comprehensive Complication index (CCI) at the 6th postoperative month
timeFrame: An average of 6 month from the date of low anterior resection for rectal cancer until the date of when the patient's condition is stabilized without complications
Secondary outcomes:
measure: Comprehensive Complication Index (CCI) at the first postoperative, 3 months postoperative, 1 year postoperative,3 years postoperative,5 years postoperative
timeFrame: 5 year
measure: First postoperative complications
timeFrame: From the date of randomization until the date of discharge, an average of 7 to 14 days
measure: Stoma-related complications
timeFrame: Through study completion, an average of 5 year
measure: Complications after ileostomy closure
timeFrame: Through study completion, an average of 5 year
measure: Postoperative hospitalization days(Initial and all subsequent hospitalizations)
timeFrame: Through study completion, an average of 5 year
measure: The number of hospitalizations(Initial and all subsequent hospitalizations)
timeFrame: Through study completion, an average of 5 year
measure: Duration of bearing the stoma (months)
timeFrame: Through study completion, an average of 5 year
measure: Total hospitalization costs(Initial and all subsequent hospitalizations)
timeFrame: Through study completion, an average of 5 year
measure: Number of participants with terminal ostomy
timeFrame: Through study completion, an average of 5 year
measure: Number of Participants with unscheduled secondary surgery
timeFrame: Through study completion, an average of 5 year
measure: The rate at which virtual ileostomy was converted to diverting ileostomy
timeFrame: Through study completion, an average of 5 year
measure: Virtual ileostomy remove time(days)
timeFrame: During hospitalization,approximately 14 days
measure: Bile acid concentration of drainage fluid
timeFrame: During hospitalization,approximately 7 days
measure: Number of participants with stoma (terminal/loop) at 6 months after initial surgery
timeFrame: 6 months from the date of first surgery for rectal cancer
measure: Interventional drainage rate
timeFrame: Through study completion, an average of 5 year
measure: Fecal Incontinence Scale(Wexner Score)
timeFrame: Through study completion, an average of 5 year
measure: Quality of life(EORTC QLQ-C30)
timeFrame: Through study completion, an average of 5 year
measure: Disease free survival (DFS)
timeFrame: Through study completion, an average of 5 year
measure: Overall survival (OS)
timeFrame: Through study completion, an average of 5 year
measure: Rate of permanent ileostomy
timeFrame: From the date of first surgery,an average of 3 year
measure: Completion of intended perioperative or adjuvant chemotherapy
timeFrame: Through study completion, an average of 5 year
measure: Low anterior resection syndrome for rectal cancer
timeFrame: Through study completion, an average of 5 year
measure: Quality of life for fecal incontinence
timeFrame: Through study completion, an average of 5 year
measure: Permanent ileostomy rate
timeFrame: 3 years from the date of first surgery for rectal cancer
measure: Mortality
timeFrame: 30 days from the date of first surgery for rectal cancer
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital, Third Military Medical University
Study officials:
affiliation: Daping Hospital, Third Military Medical University
name: fan li
role: STUDY_CHAIR
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