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.|
|ClinicalTrials.gov Identifier: NCT01040481|
Recruitment Status : Completed
First Posted : December 29, 2009
Last Update Posted : December 29, 2009
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|
|Official Title:||Laparoscopic Revisional Surgery: Adding Malabsorption for Failed Gastric Bypass|
|Study Start Date :||August 2009|
|Study Completion Date :||December 2009|
|Malabsorptive distal gastric bypass|
- Morbidity and mortality [ Time Frame: throughout follow-up ]
- Weight loss expressed as Body Mass Index and Percentage excess weight loss [ Time Frame: throughout follow-up ]
- Traditional outcome measurements [ Time Frame: Variable ]
- Remission or improvement of comorbidities [ Time Frame: throughout follow-up ]
- Health-related Quality of Life (HR-QoL) [ Time Frame: at last follow-up ]
- Subjective Satisfaction [ Time Frame: at the last follow-up ]
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 ClinicalTrials.gov identifier (NCT number): NCT01040481
|United States, California|
|UCSF Fresno Center for Medical Education and Research|
|Fresno, California, United States, 93701|
|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|