Very Long Term Results After Laparoscopic Retrocolic Antegastric Gastric Bypass (>10yrsRYGB)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Clinically Severe Obesity

Study type: Observational

Funder types: Other

Identifiers

NCT01040507

U1111-1113-0364 (Other Identifier)

CMC IRB No. 2009023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 242 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

242 participants in 1 patient group

primary laparoscopic gastric bypass