Ileal Pouch-Anal Anastomosis Registry

Ileal Pouch-Anal Anastomosis Clinical Trial

— IPAA  

Official title:

Ileal Pouch-Anal Anastomosis (IPAA) Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01026480
• Other study ID #: H-28518
• Status: Terminated
• Phase: N/A
• First received: November 25, 2009
• Last updated: March 16, 2017
• Start date: November 2009
• Est. completion date: March 16, 2017

Study information

• Verified date: March 2017
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 936
• Est. completion date: March 16, 2017
• Est. primary completion date: March 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ileal Pouch-Anal Anastomosis

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pouch status: functional pouch or non-functional pouch (diverted or excised)	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.	Once per year for duration of the study
Secondary	Quality of life	Participants will be queried once per year as to their quality of life using the IBDQ-10.	Once per year for duration of the study
Secondary	Health status	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.	Once per year for duration of the study

External Links

•   IPAA Registry at Boston Medical Center