Status:
UNKNOWN
Comparison of Functional Outcomes Between Transanal and Laparoscopic vs Open Ileal Pouch-Anal Anastomosis
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborating Sponsors:
Cedars-Sinai Medical Center
St Mary's Hospital, London
Conditions:
Ulcerative Colitis
Inflammatory Bowel Diseases
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Background: Ulcerative colitis (UC) and inflammatory bowel unclassified (IBDu) are inflammatory bowel diseases (IBD) involving the colon and rectum. It is a chronic disease occurring in young people w...
Eligibility Criteria
Inclusion
- Patients with UC or IBD-U refractory to medical therapy or with dysplasia
- Patients undergoing a 1-, 2-stage, 3-stage approach
- Between 18 years old and 60 years old.
- Speak English and/or primary language of recruiting center.
- Provide informed consent
Exclusion
- Patients with familial adenomatous polyposis (FAP);
- Patients with contraindications for laparoscopic surgery including previous laparotomy, toxic megacolon and chronic obstructive pulmonary disease (COPD) Gold III or higher;
- Patients still taking steroids at the time of proctectomy and IPAA construction. A wash-out period of 8 weeks will be considered for all treatments before performing the pouch construction.
- Patients with confirmed or suspected colorectal cancer;
- Patients with primary sclerosing cholangitis (PSC)
- Patients needing a hand-sewn anastomosis;
- Redo-pouch surgery
- Pregnancy and lactation (tested by a urinary pregnancy test)
- Patients undergoing an urgent or emergent proctocolectomy. Those patients are still eligible if they undergo a subtotal colectomy first and a completion proctectomy in a second stage.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04722757
Start Date
January 1 2021
End Date
June 30 2025
Last Update
September 6 2023
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5