Ileal Pouch-Anal Anastomosis Registry

Terminated

• Conditions: Ileal Pouch-Anal Anastomosis

• Registration Number: NCT01026480
• Lead Sponsor: Boston Medical Center

Brief Summary

Little is known about the factors that predispose patients to complications after an ileal pouch-anal anastomosis procedure (IPAA). Our goal is to establish a registry that prospectively captures pre- and post-surgical data from participants. Retrospective studies concerning IPAA outcomes and will be conducted using these data.

Detailed Description

In order to better understand the long-term outcomes following IPAA, a registry that collects pertinent information about the underlying disease and its treatments and complications in an organized manner must be established. Establishing this Registry will allow us to follow patients who have an IPAA and organize retrospective medical information into a meaningful system.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-25
• Study First Submitted QC: 2009-12-03
• Study First Posted: 2009-12-04
• Status Verified: 2017-03
• Primary Completion: 2017-03-16
• Study Completion: 2017-03-16
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-03-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 936

Inclusion Criteria

• Diagnosed with one of the following: Ulcerative colitis, Crohn's disease, Indeterminate colitis, Familial adenomatous polyposis, Hereditary nonpolyposis colorectal cancer, Lynch syndrome I or II, or Gardners' syndrome
• Treated by a Center for Digestive Disorders physician
• Scheduled for, or has undergone, ileal pouch-anal anastomosis procedure

Exclusion Criteria

• Patients who do not speak a language for which the IRB has approved an Informed Consent Form or Short Form
• Patients who are currently incarcerated

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pouch status: functional pouch or non-functional pouch (diverted or excised)	Once per year for duration of the study	Participants will be queried once per year as to the status of their intestinal pouch. Patients will have either a functional pouch or a non-functional pouch. A pouch will be considered functional if patient is not temporarily or permanently diverted to an ileostomy.

Secondary Outcome Measures

Name	Time	Method
Quality of life	Once per year for duration of the study	Participants will be queried once per year as to their quality of life using the IBDQ-10.
Health status	Once per year for duration of the study	Participants will be queried once per year regarding health issues with pouch such as pouchitis, stricture and fistula. Participants will also be asked about presence of co-morbidities such as hypertension, diabetes and arthritis.

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States