Adding Malabsorption for Failed Gastric Bypass

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01040481
First received: December 26, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Laparoscopic Revisional Surgery: Adding Malabsorption for Failed Gastric Bypass

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Morbidity and mortality [ Time Frame: throughout follow-up ] [ Designated as safety issue: Yes ]
  • Weight loss expressed as Body Mass Index and Percentage excess weight loss [ Time Frame: throughout follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Traditional outcome measurements [ Time Frame: Variable ] [ Designated as safety issue: No ]
  • Remission or improvement of comorbidities [ 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 ]

Enrollment: 19
Study Start Date: August 2009
Study Completion Date: December 2009
Groups/Cohorts
Malabsorptive distal gastric bypass

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01040481

Locations
United States, California
UCSF Fresno Center for Medical Education and Research
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:

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: NCT01040481     History of Changes
Other Study ID Numbers: CMC IRB No. 2009066, U1111-1113-0500
Study First Received: December 26, 2009
Last Updated: December 26, 2009
Health Authority: United States: Institutional Review Board

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
Reoperations
Conversions

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

ClinicalTrials.gov processed this record on July 22, 2014