Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision

Trial Title: Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision

NCT ID: NCT06633133

Condition: Rectal Cancer

Conditions: Official terms:
Rectal Neoplasms

Conditions: Keywords:
virtual ileostomy
diverting ileostomy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: Virtual ileostomy
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.
Arm group label: Virtual ileostomy

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

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Daping Hospital, Third Military Medical University

Address:
City: Chongqing
Zip: 400042
Country: China

Status: Recruiting

Contact:
Last name: fan li, PhD

Phone: +86 023 68757958
Email: levinecq@163.com

Start date: October 10, 2024

Completion date: October 1, 2030

Lead sponsor:
Agency: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Agency class: Other

Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06633133