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

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01040507
First received: December 23, 2009
Last updated: December 28, 2009
Last verified: August 2009
History of Changes
  Purpose

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.


Condition
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:

MedlinePlus related topics: Obesity
U.S. FDA Resources

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)
Groups/Cohorts
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.

  Eligibility

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.

Criteria

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 ClinicalTrials.gov identifier: NCT01040507

Locations
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
Investigators
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:
"Click here for more information about the department sponsor´s web site"  This link exits the ClinicalTrials.gov site

Publications:
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
ClinicalTrials.gov 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
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013