Bleeding Marginal Ulcer Clinical Trial
— BleedingMUOfficial title:
Endoscopic Therapy for Actively Bleeding Marginal Ulcers: Our Experience After 7,020 Roux-en-Y Gastric Bypass Surgeries
The objective of this study is to identify the incidence rate; describe the risk factors, clinical presentation, and endoscopic treatment; assess the morbidity, mortality, and overall performance of the management of patients with actively bleeding marginal ulcers after Roux-en-Y gastric bypass (RYGB) surgery.
Status | Completed |
Enrollment | 45 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - patients status post laparoscopic RYGB surgery with active gastrointestinal hemorrhage secondary to marginal ulcer Exclusion Criteria: - bleeding marginal ulcers after other bariatric procedures - staple-line bleeding after RYGB - iron-deficiency anemia (chronic) secondary to non-actively bleeding marginal ulcer after RYGB - other sources of GI bleeding different from marginal ulcer such as from staple-lines, complicated PUD, and other surgical and medical causes of GI hemorrhage - missing records and/or unreachable patients with scant information for analysis |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | UCSF Fresno Center for Medical Education and Research | Fresno | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
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* Note: There are 34 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morbidity and mortality, overall | throughout follow-up | Yes | |
Primary | re-bleeding, gastrointestinal hemorrhage secondary to marginal ulceration | throughout follow-up | Yes | |
Primary | marginal ulcer recurrence | at last follow-up | Yes | |
Primary | Symptom resolution, marginal ulcer | at last follow-up | No | |
Secondary | consumption of blood products | during bleeding-related hospitalization | No | |
Secondary | weight loss expressed as Body Mass Index and Percentage excess weight loss | at the lowest point and yearly intervals | No |