Surgical Decision Making Among People With Inflammatory Bowel Disease

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

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Disease

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Christine Rini, Ph.D., University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: February 20, 2007
• First Submitted That Met QC Criteria: February 21, 2007
• First Posted (Estimate): February 22, 2007

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2017
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: NCI K07 CA104701; GCO#03-0141 (Other Identifier: Mt Sinai); K07CA104701 (U.S. NIH Grant/Contract)