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NCT03952195 · ClinicalTrials.gov registry record
Complications and Outcomes of Pouch Excision
A clinical trial, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- 94
- Enrollment target
NCT03952195: Completed study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03952195 is a clinical trial that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 94 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03952195 has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- 94 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Number of Participants with any post operative complication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2015-11-01 |
| Est. Completion | 2018-04-01 |
What the finished NCT03952195 record still lists
NCT03952195 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 94 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03952195 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03952195 about?
NCT03952195 is a clinical study titled "Complications and Outcomes of Pouch Excision". 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 incl...
What is the current status of trial NCT03952195?
This trial is currently completed. The enrollment target is 94 participants. The study started on 2015-11-01. Estimated completion is 2018-04-01.
Who is sponsoring clinical trial NCT03952195?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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