Ileal Pouch-Anal Anastomosis Registry (IPAA)

This study is currently recruiting participants. (see Contacts and Locations)
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

November 25, 2009
June 22, 2011
November 2009
December 2050   (final data collection date for primary outcome measure)
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.
Functional outcome [ Time Frame: After surgery: yearly ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01026480 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
Not Provided
Not Provided
 
Ileal Pouch-Anal Anastomosis Registry
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Ileal Pouch-Anal Anastomosis
Not Provided
IPAA Patients
Patients who have had their IPAA procedures performed by Dr. Becker
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
December 2050
December 2050   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Lauren A Howard, MPH 617.414.8013 lauren.howard@bmc.org
Contact: Jennifer A Coukos, BS 617.638.8668 jennifer.coukos@bmc.org
United States
 
NCT01026480
H-28518
No
James M. Becker, MD, Boston Medical Center
Boston Medical Center
Not Provided
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
Boston Medical Center
June 2011

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