Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06633133

Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision

Led by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Updated on 2024-10-16

620

Participants Needed

1

Research Sites

311 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of rectal cancer confirmed by pathology
  • Age 18 years or older
  • Undergoing total mesorectal excision (TME) surgery with colon-rectum or colon-anal anastomosis including anterior resection, low anterior resection, intersphincteric abdominoperineal resection, or transanal total mesorectal excision
  • Signed informed consent
  • Ability to understand the nature and risks of participating in the trial
Not Eligible

You will not qualify if you...

  • Emergency surgery or open surgery
  • ASA score greater than 3 points
  • Combined complete intestinal obstruction
  • Long-term use of immunosuppressants or glucocorticoids
  • Severe cardiac disease including congestive heart failure or NYHA cardiac function grade 2 or higher, or history of myocardial infarction or coronary artery surgery within 6 months before procedure
  • Chronic renal failure requiring dialysis or glomerular filtration rate less than 30 mL/min
  • Intraoperative combined multi-organ resection
  • Liver cirrhosis
  • Intraoperative incomplete anastomosis or positive insufflation test
  • Modified Bacon procedure (Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis)
  • Intraoperative necessity for diverting ileostomy due to accident
  • Current participation in other clinical trials

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Daping Hospital, Third Military Medical University

Chongqing, China, 400042

Actively Recruiting

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Research Team

F

fan li, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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