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

This study has been completed.
Information provided by:
University of California, San Francisco Identifier:
First received: December 23, 2009
Last updated: December 28, 2009
Last verified: August 2009

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.

Clinically Severe Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Very Long Term Results After Laparoscopic Retrocolic Antegastric Gastric Bypass

Resource links provided by NLM:

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Weight loss expressed as Body Mass Index and Percentage excess weight loss [ Time Frame: throughout follow-up ] [ Designated as safety issue: No ]
  • Comorbidity status [ Time Frame: throughout follow-up ] [ Designated as safety issue: No ]
  • Health-related Quality of Life (HR-QoL) [ Time Frame: at last follow-up ] [ Designated as safety issue: No ]
  • Subjective satisfaction [ Time Frame: at the last follow-up ] [ Designated as safety issue: No ]
  • Morbidity and mortality [ Time Frame: throughout follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Nutritional and metabolic status [ Time Frame: throughout follow-up ] [ Designated as safety issue: No ]

Enrollment: 242
Study Start Date: June 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
primary laparoscopic gastric bypass

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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who had clinically severe obesity and underwent a primary laparoscopic Roux-en-Y Gastric Bypass more than years ago were identified form a prospectively maintained database at UCSF Fresno / ALSA med group, Inc Minimally Invasive Surgery Program.


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
  Contacts and Locations
Please refer to this study by its identifier: NCT01040507

United States, California
UCSF Fresno Center for Medical Education and Research, Department of Surgery
Fresno, California, United States, 93701
Sponsors and Collaborators
University of California, San Francisco
Study Director: Francisco M Tercero, MD Research Associate, University of California San Francisco
Principal Investigator: Kelvin D Higa, MD Professor of Surgery, University of California San Francisco
  More Information

Additional Information:
Meguid MM, Glade MJ, Middleton FA. Weight gain after Roux-en-Y: a significant 20% complication related to PYY. Nutrition 2008; 24:232-42.

Responsible Party: Kelvin D Higa, MD; FACS; FASMBS; Professor of Surgery, University of California San Francisco, UCSF Fresno / ALSA Medical Group, Inc. Minimally Invasive Surgery Program Identifier: NCT01040507     History of Changes
Other Study ID Numbers: CMC IRB No. 2009023, U1111-1113-0364
Study First Received: December 23, 2009
Last Updated: December 28, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
severe obesity
morbid obesity
gastric bypass
efficacy of gastric bypass

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on April 17, 2014