Clinically Severe Obesity Clinical Trial
Official title:
Laparoscopic Revisional Surgery: Adding Malabsorption for Failed Gastric Bypass
The main aim of this study is to analyze and report the preliminary and intermediate term
outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for weight recidivism.
The foremost outcome measurements are 1) Fat loss mainly measured as weight loss and
expressed as trends in BMI, %EWL, and/or %EBL; 2) Trend in Comorbidity status; and 3)
Patient satisfaction and Health-Related Quality of Life "HR-QoL" measured by a standardized,
non-validated subjective satisfaction questionnaire and the validated, disease-specific,
Moorehead-Ardelt II QoL questionnaires, respectively; 4) Morbidity & Mortality including
nutritional status and metabolic complications.
Consequently, secondary objectives of this study are 1) to assess failure rate defined as
percentage of excess weight loss < 50% , lowest BMI >35 for morbidly obese (MO) or >40 for
superobese (SO), and/or lack of resolution/improvement of major comorbidities at the point
in time when assessing preliminary and intermediate results after the surgery under
analysis. 2) To evaluate the metabolic and nutritional status by measurements of particular
clinical and biochemical parameters.
This research is in line with the most current provocative new ideas and recent high impact
publications. To the best of our knowledge, this is the very first outcome study of
revisional malabsorptive distal gastric bypass surgery by laparoscopy with diverse
revisional strategies such as revisional gastroplasty, revisional Fobi-Capella, revisional
Adjustable Gastric Band, conversion to distal, and conversion to very, very long limb
gastric bypass. Previously, several studies have addressed conversion to malabsorptive
gastric bypass after a failed primary proximal gastric bypass but none has addressed the
failed distal gastric bypass nor the adequate balance between increasing restriction and
malabsorption for decreasing the risk of protein-calorie malnutrition.
Status | Completed |
Enrollment | 19 |
Est. completion date | December 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients who met NIH criteria for recommendation of a bariatric procedure with the combination of the following characteristics: - Failed primary proximal gastric bypass with subsequent revision to a malabsortive distal gastric bypass. - Failed primary distal malabsorptive gastric bypass with subsequent revision to increase the restrictive component (revisional: gastroplasty, Fobi, or adjustable gastric band) Exclusion Criteria: - Patients with prior major conversions or revisions. - 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 33 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morbidity and mortality | throughout follow-up | Yes | |
Primary | Weight loss expressed as Body Mass Index and Percentage excess weight loss | throughout follow-up | No | |
Secondary | Traditional outcome measurements | Variable | No | |
Secondary | Remission or improvement of comorbidities | throughout follow-up | No | |
Secondary | Health-related Quality of Life (HR-QoL) | at last follow-up | No | |
Secondary | Subjective Satisfaction | at the last follow-up | No |
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