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Adding Malabsorption for Failed Gastric Bypass

NCT01040481 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 19

Last updated 2009-12-29

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Francisco M Tercero, MD · Research Associate, University of California San Francisco

  • Kelvin D Higa, MD · Professor of Surgery, University of California San Francisco

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01040481 on ClinicalTrials.gov