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Very Long Term Results After Laparoscopic Retrocolic Antegastric Gastric Bypass (>10yrsRYGB)
This study has been completed.
Sponsor:
University of California, San Francisco
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
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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 |
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 ]
- Comorbidity status [ Time Frame: throughout follow-up ]
- Health-related Quality of Life (HR-QoL) [ Time Frame: at last follow-up ]
- Subjective satisfaction [ Time Frame: at the last follow-up ]
- Morbidity and mortality [ Time Frame: throughout follow-up ]
Secondary Outcome Measures:
- Nutritional and metabolic status [ Time Frame: throughout follow-up ]
| 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 (Adult) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01040507
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:
Publications:
www.asbs.org/htm/Private/resolution.html. American Society of Metabolic and Bariatric Surgeons.
| 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 ( Other Identifier: World Health Organization, Universal Trial Number ) |
| Study First Received: | December 23, 2009 |
| Last Updated: | December 28, 2009 |
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 July 26, 2017