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Trial record 20 of 27 for:    15479938 [PUBMED-IDS]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01040507
Recruitment Status : Completed
First Posted : December 29, 2009
Last Update Posted : December 29, 2009
Information provided by:
University of California, San Francisco

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

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.

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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

primary laparoscopic gastric bypass

Primary Outcome Measures :
  1. Weight loss expressed as Body Mass Index and Percentage excess weight loss [ Time Frame: throughout follow-up ]
  2. Comorbidity status [ Time Frame: throughout follow-up ]
  3. Health-related Quality of Life (HR-QoL) [ Time Frame: at last follow-up ]
  4. Subjective satisfaction [ Time Frame: at the last follow-up ]
  5. Morbidity and mortality [ Time Frame: throughout follow-up ]

Secondary Outcome Measures :
  1. Nutritional and metabolic status [ Time Frame: throughout follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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.

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

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 identifier (NCT number): NCT01040507

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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
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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: American Society of Metabolic and Bariatric Surgeons.

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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 ( 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:
severe obesity
morbid obesity
gastric bypass
efficacy of gastric bypass
Additional relevant MeSH terms:
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Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms