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Complications and Outcomes of Pouch Excision

NCT03952195 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 94

Last updated 2019-05-16

No results posted yet for this 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.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Joel J Bauer, MD · Icahn School of Medicine at Mount Sinai

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-01
Primary Completion
2017-04-01
Completion
2018-04-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03952195 on ClinicalTrials.gov