Very Long Term Results After Laparoscopic Retrocolic Antegastric Gastric Bypass

Completed

• Conditions: Clinically Severe Obesity

• Registration Number: NCT01040507
• Lead Sponsor: University of California, San Francisco

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 Timeline

• Study Start: 2009-06
• Status Verified: 2009-08
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2009-12-23
• Study First Submitted QC: 2009-12-28
• Last Update Submitted: 2009-12-28
• Study First Posted: 2009-12-29
• Last Update Posted: 2009-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight loss expressed as Body Mass Index and Percentage excess weight loss	throughout follow-up
Comorbidity status	throughout follow-up
Health-related Quality of Life (HR-QoL)	at last follow-up
Subjective satisfaction	at the last follow-up
Morbidity and mortality	throughout follow-up

Secondary Outcome Measures

Name	Time	Method
Nutritional and metabolic status	throughout follow-up

Trial Locations

Locations (1)

UCSF Fresno Center for Medical Education and Research, Department of Surgery; 🇺🇸 Fresno, California, United States