Very Long Term Results After Laparoscopic Retrocolic Antegastric Gastric Bypass (>10yrsRYGB)
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| ClinicalTrials.gov Identifier: NCT01040507 |
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Recruitment Status
:
Completed
First Posted
: December 29, 2009
Last Update Posted
: December 29, 2009
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Sponsor:
University of California, San Francisco
Information provided by:
University of California, San Francisco
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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.
| Condition or disease |
|---|
| Clinically Severe Obesity |
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.
| Study Type : | Observational |
| Actual Enrollment : | 242 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Very Long Term Results After Laparoscopic Retrocolic Antegastric Gastric Bypass |
| Study Start Date : | June 2009 |
| Actual Primary Completion Date : | December 2009 |
| Actual Study Completion Date : | December 2009 |
| Group/Cohort |
|---|
| primary laparoscopic gastric bypass |
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 ]
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| 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:
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
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 ) |
| First Posted: | December 29, 2009 Key Record Dates |
| Last Update Posted: | December 29, 2009 |
| Last Verified: | August 2009 |
Keywords provided by University of California, San Francisco:
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severe obesity morbid obesity gastric bypass efficacy of gastric bypass |
Additional relevant MeSH terms:
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Obesity Obesity, Morbid Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |