Trials / Completed
CompletedNCT01040507
Very Long Term Results After Laparoscopic Retrocolic Antegastric Gastric Bypass
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 242 (actual)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2009-12-01
- Completion
- 2009-12-01
- First posted
- 2009-12-29
- Last updated
- 2009-12-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01040507. Inclusion in this directory is not an endorsement.