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 ] [ 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 (Adult) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 |
| 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 September 26, 2016