Adding Malabsorption for Failed Gastric Bypass
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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 |
- 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 ]
- 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 (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
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:
|
Obesity Weight Loss Malabsorption Syndromes Obesity, Morbid Overnutrition Nutrition Disorders Overweight |
Body Weight Signs and Symptoms Body Weight Changes Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases |
ClinicalTrials.gov processed this record on September 30, 2016