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

Tracking Information

First Received Date ^ICMJE

November 25, 2009

Last Updated Date

June 22, 2011

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

December 2050 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Functional outcome [ Time Frame: After surgery: yearly ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01026480 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Quality of life [ Time Frame: After surgery: yearly ] [ Designated as safety issue: No ]
Health status [ Time Frame: After surgery: yearly ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ileal Pouch-Anal Anastomosis Registry

Official Title ^ICMJE

Ileal Pouch-Anal Anastomosis (IPAA) Registry

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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

Condition ^ICMJE

Ileal Pouch-Anal Anastomosis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

IPAA Patients

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1500

Estimated Completion Date

December 2050

Estimated Primary Completion Date

December 2050 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01026480

Other Study ID Numbers ^ICMJE

H-28518

Has Data Monitoring Committee

Responsible Party

James M. Becker, MD, Boston Medical Center

Study Sponsor ^ICMJE

Boston Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Boston Medical Center

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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