Ulcerative Colitis Clinical Trial
Official title:
Ileal Pouch Salvage and Excision Operations: Indications, Complications and Outcomes
NCT number | NCT03952195 |
Other study ID # | GCO 16-0172 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2015 |
Est. completion date | April 1, 2018 |
Verified date | May 2019 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Procedure is offered today to most patients with chronic ulcerative colitis (CUC) or familial adenomatous polyposis (FAP) who are candidates for total proctocolectomy. While high rates of successful pouch surgery are reported, there is a significant long-term risk of pouch-related complications including ileo-anal anastomotic separation and stricture, pouch-perineal and pouch-vaginal fistula, pouchitis, pelvic sepsis, small bowel obstruction, and pouch dysfunction. Despite recent advances in treatment of these complications by medical and surgical means, these problems can still lead to pouch failure and pouch excision. The long-term rate of pouch excision is reported in large series to range from 5.3% to 24%. Moreover, the burden of quality of life impairment on patients with these complications is immense. Pouch excision operations are technically difficult with substantial morbidity. This study aimed to investigate the indications for pouch excision, the number of salvage operations prior to these excisions and complications of pouch excision surgeries.
Status | Completed |
Enrollment | 94 |
Est. completion date | April 1, 2018 |
Est. primary completion date | April 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - All patients undergoing pouch excision Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with complications | Number of Participants with any post operative complication | Five years |
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