Complications and Outcomes of Pouch Excision

NCT03952195 | Completed

• 1 other identifier: GCO 16-0172
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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

Ulcerative Colitis; Inflammatory Bowel Diseases

Keywords

IPAA; IBD; Ulcerative Colitis; Restorative Proctocolectomy; Ileal Pouch-Anal Anastomosis; Excisions; Salvage; Pouch

Outcome Measures

Primary Outcomes (1)

• Number of Participants with complications

  Number of Participants with any post operative complication

  Five years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have had an their pouch excised

You may qualify if:

• All patients undergoing pouch excision

You may not qualify if:

• None

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Joel J Bauer, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 16, 2019
• Study Start: November 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2018
• Last Updated: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)