Surgical Decision Making Among People With Inflammatory Bowel Disease

Inflammatory Bowel Disease Clinical Trial

Official title:

Surgical Decision Making Among People With Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438711
• Other study ID #: NCI K07 CA104701
• Secondary ID: GCO#03-0141K07CA
• Status: Completed
• Phase: N/A
• First received: February 20, 2007
• Last updated: November 14, 2017
• Start date: September 2005
• Est. completion date: December 2008

Study information

• Verified date: July 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,