Surgical Decision Making Among People With Inflammatory Bowel Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00438711
First received: February 20, 2007
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

This is a study for people with inflammatory bowel disease ("IBD"--that is, ulcerative colitis, Crohn's colitis, or indeterminate colitis). We are studying how people with IBD decide to have surgery when a doctor has told them they should think about having their colon (large bowel) removed. This surgery is called a "colectomy." Patients will be asked to fill out a questionnaire that takes about 60 to 90 minutes to complete. Questions ask about patients' background (age, etc.) and their IBD. They also ask about patients' decision to have surgery or not to have surgery. For instance, what kinds of things did they think about? Some questions ask about other people who affected the choice and how patients felt about the help they got from others. People who wish to join the study will receive payment to thank them for their time.

  • Patients must be at least 18 years old
  • Patients must speak English
  • Patients must have been told by their doctor to think about having surgery to take out their colon to (a) lower their risk for cancer or (b) because they have pre-cancer (called "dysplasia")
  • Patients do not need to have had the surgery--they may have already had the surgery, they may not have had it yet, or they may have decided they do not want to have it

Condition
Inflammatory Bowel Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Surgical Decision Making Among People With Inflammatory Bowel Disease

Further study details as provided by University of North Carolina, Chapel Hill:

Enrollment: 91
Study Start Date: September 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People with inflammatory bowel disease who respond to advertisements and study announcements or who were treatment at the recruitment site and referred by their physician.

Criteria

Inclusion Criteria:

  1. Have been told by a doctor that they have ulcerative colitis, Crohn's disease, or indeterminate colitis.
  2. Be at least 18 years old
  3. Speak English
  4. Have been told by a doctor to think about having surgery to take out their colon ("colectomy") within the last 3 years
  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: NCT00438711

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Christine Rini, Ph.D. University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Christine Rini, Ph.D., Research Assistant Professor, University of North Carolina at Chapel Hill
ClinicalTrials.gov Identifier: NCT00438711     History of Changes
Other Study ID Numbers: NCI K07 CA104701, GCO#03-0141, K07CA104701
Study First Received: February 20, 2007
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 19, 2014