Abdominal Pain Clinical Trial
Official title:
Evaluation of Gastrointestinal Symptoms and Quality of Life in Patients With Sphincter of Oddi Dysfunction: Evaluation of the Differences Between Those Undergoing Endoscopic Therapy vs.Conservative Care
Verified date | August 2011 |
Source | Wisconsin Center for Advanced Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | USA: Institutional Review Board |
Study type | Observational |
The purpose of this research study is to see if there is a significant difference in improvement of symptoms and quality of life of those undergoing endoscopic therapy versus those wanting to control their symptoms with medicines or those who just want to wait and watch.
Status | Terminated |
Enrollment | 153 |
Est. completion date | August 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - over age 18 - suspected history and clinical features suggestive of sphincter of oddi dysfunction Exclusion Criteria: - prior history of endoscopic therapy for sphincter of oddi dysfunction - no proven sphincter of oddi dysfunction on manometry |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Wisconsin Center for Advanced Research | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Wisconsin Center for Advanced Research | Aurora Health Care |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | symptom improvement | one year | No | |
Secondary | improved quality of life | one year | No |
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