Ileal Pouch-Anal Anastomosis Registry (IPAA)

March 16, 2017 updated by: Francis Farraye, MD, Boston Medical Center

Ileal Pouch-Anal Anastomosis (IPAA) Registry

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

936

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for, or who have undergone, ileal pouch-anal anastomosis (IPAA) procedure and have been treated by a Center for Digestive Disorders physician at Boston Medical Center

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
IPAA Patients
Patients who have had their IPAA procedures performed by Dr. Becker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pouch status: functional pouch or non-functional pouch (diverted or excised)
Time Frame: 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.
Once per year for duration of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 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.
Once per year for duration of the study
Health status
Time Frame: 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.
Once per year for duration of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Investigators

  • Principal Investigator: James M Becker, MD, Boston Medical Center
  • Study Director: Francis A Farraye, MD, Boston Medical Center
  • Study Director: Arthur F Stucchi, PhD, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

March 16, 2017

Study Completion (Actual)

March 16, 2017

Study Registration Dates

First Submitted

November 25, 2009

First Submitted That Met QC Criteria

December 3, 2009

First Posted (Estimate)

December 4, 2009

Study Record Updates

Last Update Posted (Actual)

March 17, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-28518

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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