Inflammatory Bowel DiseaseNCT00438711
Surgical Decision Making Among People With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Have been told by a doctor that they have ulcerative colitis, Crohn's disease, or indeterminate colitis.
- Be at least 18 years old
- Speak English
- Have been told by a doctor to think about having surgery to take out their colon ("colectomy") within the last 3 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
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
- Conditions
- Inflammatory Bowel Disease
- Medical subject headings
- Inflammatory Bowel Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startSep 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christine Rini, Ph.D., Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438711
- Sponsor's protocol ID
- NCI K07 CA104701
- Other IDs
- GCO#03-0141, K07CA104701
- Status last verified
- Jul 2011
- First submitted
- 20 Feb 2007
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Decision Making Among People With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT00438711
- Acronym / sponsor ID
- NCI K07 CA104701
- Conditions
- Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Have been told by a doctor that they have ulcerative colitis, Crohn's disease, or indeterminate colitis.
- Be at least 18 years old
- Speak English
- Have been told by a doctor to think about having surgery to take out their colon ("colectomy") within the last 3 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Rini, Ph.D. principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.