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Very Long Term Results After Laparoscopic Retrocolic Antegastric Gastric Bypass

Very Long Term Results After Laparoscopic Retrocolic Antegastric Gastric Bypass

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01040507
Acronym
>10yrsRYGB
Enrollment
242
Registered
2009-12-29
Start date
2009-06-30
Completion date
2009-12-31
Last updated
2009-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinically Severe Obesity

Keywords

severe obesity, morbid obesity, gastric bypass, efficacy of gastric bypass

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.

Interventions

None listed

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
Morbidity and mortalitythroughout follow-up
Weight loss expressed as Body Mass Index and Percentage excess weight lossthroughout follow-up
Comorbidity statusthroughout follow-up
Health-related Quality of Life (HR-QoL)at last follow-up
Subjective satisfactionat the last follow-up

Secondary

MeasureTime frame
Nutritional and metabolic statusthroughout follow-up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026