Comparing surgical methods for ileal pouch-anal anastomosis in ulcerative colitis patients
Functional Outcomes of Transanal Ileal Pouch-Anal Anastomosis Compared to Laparoscopic or Open Ileal Pouch-Anal Anastomosis: a Multi-Center, Randomized, Parallel-Group, Non-Inferiority Trial
This study is testing whether a newer, less invasive surgical method for creating a pouch in the intestines works as well as the traditional laparoscopic approach for people with ulcerative colitis who need surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Mount Sinai Hospital, Canada Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04722757 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the functional outcomes of two surgical techniques for ileal pouch-anal anastomosis (IPAA) in patients with ulcerative colitis and inflammatory bowel diseases. One technique is the traditional laparoscopic approach, while the other is a newer, less invasive transanal method. The study will evaluate whether the transanal approach offers similar or improved postoperative functional outcomes compared to the laparoscopic method. Eligible participants will be those who have not responded to medical therapy and require surgical intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with ulcerative colitis or inflammatory bowel disease unclassified who are refractory to medical therapy.
Not a fit: Patients with contraindications for laparoscopic surgery or those with certain comorbidities, such as colorectal cancer or primary sclerosing cholangitis, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical options and outcomes for patients with ulcerative colitis requiring ileal pouch-anal anastomosis.
How similar studies have performed: While there is limited data on the functional outcomes of transanal ileal pouch-anal anastomosis, other studies have shown promising results with less invasive surgical techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with UC or IBD-U refractory to medical therapy or with dysplasia 2. Patients undergoing a 1-, 2-stage, 3-stage approach 3. Between 18 years old and 60 years old. 4. Speak English and/or primary language of recruiting center. 5. Provide informed consent Exclusion Criteria: 1. Patients with familial adenomatous polyposis (FAP); 2. Patients with contraindications for laparoscopic surgery including previous laparotomy, toxic megacolon and chronic obstructive pulmonary disease (COPD) Gold III or higher; 3. 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. 4. Patients with confirmed or suspected colorectal cancer; 5. Patients with primary sclerosing cholangitis (PSC) 6. Patients needing a hand-sewn anastomosis; 7. Redo-pouch surgery 8. Pregnancy and lactation (tested by a urinary pregnancy test) 9. 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.
Where this trial is running
Toronto, Ontario
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Anthony de Buck, MD, MSc
- Email: anthony.debuck@sinaihealth.ca
- Phone: 4165864800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.