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Ileal Pouch-Anal Anastomosis Registry (IPAA)

This study has been terminated.
(Researchers leading this study have left BMC)
Sponsor:
Information provided by (Responsible Party):
Francis Farraye, MD, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01026480
First received: November 25, 2009
Last updated: March 16, 2017
Last verified: March 2017
  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:


Further study details as provided by Francis Farraye, MD, 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 ]
    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 ]
    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 ]
    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.


Enrollment: 936
Study Start Date: November 2009
Study Completion Date: March 16, 2017
Primary Completion Date: March 16, 2017 (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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Boston Medical Center
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:
Responsible Party: Francis Farraye, MD, Faculty member, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01026480     History of Changes
Other Study ID Numbers: H-28518
Study First Received: November 25, 2009
Last Updated: March 16, 2017

Keywords provided by Francis Farraye, MD, 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 22, 2017