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Adding Malabsorption for Failed Gastric Bypass

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: NCT01040481
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 preliminary and intermediate term outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for weight recidivism. The foremost outcome measurements are 1) Fat loss mainly measured as weight loss and expressed as trends in BMI, %EWL, and/or %EBL; 2) Trend in Comorbidity status; and 3) Patient satisfaction and Health-Related Quality of Life "HR-QoL" measured by a standardized, non-validated subjective satisfaction questionnaire and the validated, disease-specific, Moorehead-Ardelt II QoL questionnaires, respectively; 4) Morbidity & Mortality including nutritional status and metabolic complications.

Consequently, secondary objectives of this study are 1) to assess failure rate defined as percentage of excess weight loss < 50% , lowest BMI >35 for morbidly obese (MO) or >40 for superobese (SO), and/or lack of resolution/improvement of major comorbidities at the point in time when assessing preliminary and intermediate results after the surgery under analysis. 2) To evaluate the metabolic and nutritional status by measurements of particular clinical and biochemical parameters.

This research is in line with the most current provocative new ideas and recent high impact publications. To the best of our knowledge, this is the very first outcome study of revisional malabsorptive distal gastric bypass surgery by laparoscopy with diverse revisional strategies such as revisional gastroplasty, revisional Fobi-Capella, revisional Adjustable Gastric Band, conversion to distal, and conversion to very, very long limb gastric bypass. Previously, several studies have addressed conversion to malabsorptive gastric bypass after a failed primary proximal gastric bypass but none has addressed the failed distal gastric bypass nor the adequate balance between increasing restriction and malabsorption for decreasing the risk of protein-calorie malnutrition.

Condition or disease
Clinically Severe Obesity Obesity Recidivism Inadequate Initial Weight Loss Poor Weight Loss Persistent Obesity Refractory Obesity Intractable Obesity

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Laparoscopic Revisional Surgery: Adding Malabsorption for Failed Gastric Bypass
Study Start Date : August 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Malabsorptive distal gastric bypass

Primary Outcome Measures :
  1. Morbidity and mortality [ Time Frame: throughout follow-up ]
  2. Weight loss expressed as Body Mass Index and Percentage excess weight loss [ Time Frame: throughout follow-up ]

Secondary Outcome Measures :
  1. Traditional outcome measurements [ Time Frame: Variable ]
  2. Remission or improvement of comorbidities [ 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 ]

Information from the National Library of Medicine

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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 either clinically severe obesity (morbid obesity, MO, or super obesity, SO) underwent a primary Roux-en-Y gastric bypass. The ones that were subsequently revised ending up with an optimized malabsorptive distal gastric bypass were identified from our prospectively maintained bariatric database and included in this study. Specific metabolic and nutritional complications after RYGB surgery were defined according to standard definitions based on signs, symptoms, and laboratory measurements.

Inclusion Criteria:

  • Patients who met NIH criteria for recommendation of a bariatric procedure with the combination of the following characteristics:

    • Failed primary proximal gastric bypass with subsequent revision to a malabsortive distal gastric bypass.
    • Failed primary distal malabsorptive gastric bypass with subsequent revision to increase the restrictive component (revisional: gastroplasty, Fobi, or adjustable gastric band)

Exclusion Criteria:

  • Patients with prior major conversions or revisions.
  • 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): NCT01040481

United States, California
UCSF Fresno Center for Medical Education and Research
Fresno, California, United States, 93701
Sponsors and Collaborators
University of California, San Francisco
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 for 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 Identifier: NCT01040481     History of Changes
Other Study ID Numbers: CMC IRB No. 2009066
U1111-1113-0500 ( Other Identifier: World Health Organization, Universal Trial Number )
First Posted: December 29, 2009    Key Record Dates
Last Update Posted: December 29, 2009
Last Verified: December 2009

Keywords provided by University of California, San Francisco:
Failed gastric bypass
Malabsorptive distal gastric bypass
Distal gastric bypass
Malabsorptive gastric bypass
Adding malabsorption
Increasing malabsorption
Re-operative bariatric surgery
Revisional bariatric surgery
Revisional gastric bypass

Additional relevant MeSH terms:
Body Weight
Weight Loss
Malabsorption Syndromes
Obesity, Morbid
Nutrition Disorders
Signs and Symptoms
Body Weight Changes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases