Surgical Decision Making Among People With Inflammatory Bowel Disease
| Tracking Information | |||||
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| First Received Date ICMJE | February 20, 2007 | ||||
| Last Updated Date | July 19, 2011 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00438711 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Surgical Decision Making Among People With Inflammatory Bowel Disease | ||||
| Official Title ICMJE | Surgical Decision Making Among People With Inflammatory Bowel Disease | ||||
| Brief 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.
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE | Inflammatory Bowel Disease | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 91 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00438711 | ||||
| Other Study ID Numbers ICMJE | NCI K07 CA104701, GCO#03-0141, K07CA104701 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Christine Rini, Ph.D., Research Assistant Professor, University of North Carolina at Chapel Hill | ||||
| Study Sponsor ICMJE | University of North Carolina, Chapel Hill | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | University of North Carolina, Chapel Hill | ||||
| Verification Date | July 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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