Very Long Term Results After Laparoscopic Retrocolic Antegastric Gastric Bypass
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 242
- Locations
- 1
- Primary Endpoint
- Weight loss expressed as Body Mass Index and Percentage excess weight loss
Study Overview
Brief Summary
The main aim of this study is to analyze and report the very long-term outcomes after primary laparoscopic proximal Roux-en-Y gastric bypass surgery for clinically severe obesity.
Detailed Description
There is lack of very-long term outcomes after bariatric surgery; A few series have been reported. However, most of them analyze medium-term outcomes. For RYGB, there are just two retrospective cohort studies reporting very long-term outcomes. Both studies have an open approach and a proximal Roux-en-Y configuration with different pouch orientation and size. MacLean´s series, with a better follow-up rate (83.4%), had a 67.6%EWL at a mean of 11.4 years; Failure rates were 20 and 35% for the morbidly obese and super obese, respectively. We will analyze our own series with a laparoscopic approach, vertically, lesser-curve base < 10-15ml pouch and proximal Roux limb. The main end-points for our study are 1) Morbidity including status of specific biochemical markers & Mortality, 2) Weight loss expressed as BMI or %EWL, 3) Trends in major comorbidities and 4) Assessment of Quality of Life.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients who met NIH criteria for recommendation of a bariatric procedure with a combination of the following characteristics
- •status post primary laparoscopic proximal RYGB surgery with or without subsequent open or laparoscopic revisions or re-operations
- •follow up > 10.0 years (Very long term outcome)
Exclusion Criteria
- •patients who had a previous gastric or bariatric procedure
- •patients who underwent primary laparoscopic RYGB somewhere else by other surgical group
- •missing records and/or unreachable patients with scant information for analysis
Outcomes
Primary Outcomes
Weight loss expressed as Body Mass Index and Percentage excess weight loss
Time Frame: throughout follow-up
Comorbidity status
Time Frame: throughout follow-up
Health-related Quality of Life (HR-QoL)
Time Frame: at last follow-up
Subjective satisfaction
Time Frame: at the last follow-up
Morbidity and mortality
Time Frame: throughout follow-up
Secondary Outcomes
- Nutritional and metabolic status(throughout follow-up)