Adding Malabsorption for Failed Gastric Bypass

Completed

Conditions studied: Clinically Severe Obesity, Obesity Recidivism, Inadequate Initial Weight Loss, Poor Weight Loss, Persistent Obesity, Refractory Obesity, Intractable Obesity

In brief

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.

Key facts

Study ID

NCT01040481

Run by

University of California, San Francisco

People needed

19

Starts

2009-08-01

Expected to finish

2009-12-01

Last updated by the study team

2009-12-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Patients with prior major conversions or revisions.
• Missing records and/or unreachable patients with scant information for analysis.

Where it is running

• UCSF Fresno Center for Medical Education and Research — Fresno, California, United States

Full record on ClinicalTrials.gov

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