Surgical Decision Making Among People With Inflammatory Bowel Disease

NCT ID: NCT00438711

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Inflammatory Bowel Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Rini, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Mount Sinai School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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GCO#03-0141

Identifier Type: OTHER

Identifier Source: secondary_id

K07CA104701

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI K07 CA104701

Identifier Type: -

Identifier Source: org_study_id