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Ileal Pouch-Anal Anastomosis Registry (IPAA)

This study is currently recruiting participants.
Verified June 2011 by Boston Medical Center
Sponsor:
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01026480
First received: November 25, 2009
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition
Ileal Pouch-Anal Anastomosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ileal Pouch-Anal Anastomosis (IPAA) Registry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Pouch status: functional pouch or non-functional pouch (diverted or excised) [ Time Frame: Once per year for duration of the study ] [ Designated as safety issue: No ]
    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:
  • Quality of life [ Time Frame: Once per year for duration of the study ] [ Designated as safety issue: No ]
    Participants will be queried once per year as to their quality of life using the IBDQ-10.

  • Health status [ Time Frame: Once per year for duration of the study ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1500
Study Start Date: November 2009
Estimated Study Completion Date: December 2050
Estimated Primary Completion Date: December 2050 (Final data collection date for primary outcome measure)
Groups/Cohorts
IPAA Patients
Patients who have had their IPAA procedures performed by Dr. Becker

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026480

Contacts
Contact: Lauren A Howard, MPH 617.414.8013 lauren.howard@bmc.org
Contact: Jennifer A Coukos, BS 617.638.8668 jennifer.coukos@bmc.org

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
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
  More Information

Additional Information:
IPAA Registry at Boston Medical Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: James M. Becker, MD, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01026480     History of Changes
Other Study ID Numbers: H-28518
Study First Received: November 25, 2009
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
Ileal Pouch Anal Anastomosis
IPAA
Pull through
IBD
Ulcerative colitis
 Familial adenomatous polyposis
FAP
Hereditary nonpolyposis colorectal cancer
HNPCC

ClinicalTrials.gov processed this record on June 18, 2013