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Adding Malabsorption for Failed Gastric Bypass

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ClinicalTrials.gov Identifier: NCT01040481
Recruitment Status : Completed
First Posted : December 29, 2009
Last Update Posted : December 29, 2009
Sponsor:
Information provided by:
University of California, San Francisco

Tracking Information
First Submitted Date December 26, 2009
First Posted Date December 29, 2009
Last Update Posted Date December 29, 2009
Study Start Date August 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: December 26, 2009)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 26, 2009)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Adding Malabsorption for Failed Gastric Bypass
Official Title Laparoscopic Revisional Surgery: Adding Malabsorption for Failed Gastric Bypass
Brief 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.

Detailed Description

Since 1998, there has been a substantially progressive increase in bariatric surgery. In 2005, the American Society of Metabolic and Bariatric Surgery (ASMBS) reported that 81% of bariatric procedures were approached laparoscopically. 205,000 people, in 2007, had bariatric surgery in the United States from which approximately 80% of these were Gastric Bypass. Moreover, there is a mismatch between eligibility and receipt of bariatric surgery with just less than 1% of the eligible population being treated for morbid obesity through bariatric surgery. Along with the increasing number of elective primary weight loss procedures, up to 20% of post RYGB patients cannot sustain their weight loss beyond 2 to 3 years after the primary bariatric procedure11. Thus, revisional surgery for poor weight loss and re-operations for technical or mechanical complications will rise in a parallel manner. RYGB is consistently considered the revisional procedure of choice for failed restrictive procedures.

At present there are three broad categories of bariatric procedures according to its mechanism of action: 1) purely restrictive, 2) primarily restrictive with some malabsorption, and 3) primarily malabsorptive with some restriction. Modern standard bariatric procedures recognized by the American Society for Metabolic and Bariatric Surgery "ASMBS" include the following 1) adjustable gastric band, 2) sleeve gastrectomy, 3) gastric bypass, 4) biliopancreatic diversion, and 5) duodenal switch.

In general, there is a lack of long-term (5-10 years) and very long-term (> 10 years) outcome studies for modern bariatric surgery that would allow us to better define the role of each one of these procedures, especially after the advent of the laparoscopic approach.

In an animal model, diet induced obese animals exhibiting metabolic syndrome underwent Roux-en-Y gastric bypass with highly reproducible surgical outcomes as well as biochemical and energetic homeostatic abnormalities similar to post-RYGB findings in humans. Weight regain occurs in approximately 20% of patients after two to three years after RYGB. It seems that the weight-loss-promoting effects of chronically elevated plasma PYY concentrations dominate the weight-gain-promoting effects of lowered plasma leptin concentrations, with the relative plasma PYY: leptin concentration ratio determining whether weight loss will be sustained or regained.

Several studies have compared different Roux limb lengths in primary bariatric surgery. It seems to be that long limb RYGB (150cm), especially in patients with BMI > 50 kg/m2, confers at least better short-term weight loss without nutritional consequences. Conversely, other investigators have not found any clinically significant difference in weight loss with increasing Roux limb lengths, especially in patients with BMI < 50 kg/m2 23-26. The following are the main investigators that have increased the malabsorptive component of the failed proximal gastric bypass as a revisional strategy:

  1. Torres JC in 1991 was the first to propose this strategy with a cohort of 140 patients followed for 5 years (90.5% follow-up rate). Analyzed traditional outcome measures were early (2.1%) and late (27%) morbidity including protein-calorie malnutrition (7%); %EWL at 1,2,3,4,and 5 years were 89.5%, 91%, 87%, 82.5%, 82.5%, respectively; and re-operations.
  2. Fox SR and Oh KH et al in 1996 reported 10 failed proximal gastric bypass patients undergoing distal gastric bypass from an diverse group of failed primary surgeries (n=80) followed for 3 years with a 92.5% follow-up rate. Reported traditional outcome measures were early (39%) and late (84%) morbidity; %EWL at 1,2,&3 years was 83%, 89%and 94%, respectively; high satisfaction was also reported.
  3. Sugerman et al in 1997 published their outcomes with 27 patients. Five patients were converted to a malabsortive distal gastric bypass with a 50cm common channel which required a second revision for malnutrition and two died. 22 patients were revised to a 150cm common channel; three patients required a second revision for malnutrition but %EWL went from 30% to 61% at 1 year and 69% at 5 years. They concluded that a 50cm common channel had an unacceptable morbidity and mortality.
  4. Fobi et al in 2000 presented his results of 65 patients after mostly failed primary Fobi pouch operation. 15 patients developed protein calorie malnutrition requiring supplemental nutrition and 6 required further revision.
  5. The 2001 Sapala´s et al partial outcome analysis on 303 varied revisionary micropouch gastric bypass procedures with a 200cm Roux limb, 150cm biliopancreatic limb and >200cm common channel. %EWL during 3 years is similar to the primary procedure (68.6%, 76.6%, and 72.3%). However no subset analysis is performed.
  6. Pareja et al analysis of 41 patients, undergoing diverse distal malabsorptive techniques, included 32 revisionary procedures after primary Fobi-Capella gastric bypass. At 11, 16, and 19 months of mean follow-up, %EWL for the Scopinaro-style, Brolin, and Fobi revisionary gastric bypasses were 69.7%, 65.0%, 74.8%, respectively. Failure and success rates according to Biron et al. are provided but no other subgroup analysis is provided.
  7. Brolin et al on 2007 reported 47 out of 54 patients undergoing revision for failed primary bariatric surgery had a very, very long limb gastric bypass with a 75cm to 100cm common channel and a 15cm to 25cm biliopancreatic limb. 7.4% (n=4) developed protein-calorie malnutrition from which one required 6 weeks of TPN, two elongation of the common channel (150cm) and one reversal after a prolonged hiatus returning with severe metabolic complications. 47.9% of the series lost at least 50% EWL at 1 year. There was no difference between those with primary failed restrictive vs. primary failed gastric bypass patients.
  8. Sarr et al on 2007 states that "patients with anatomically intact, non-malabsorptive RYGB when converted to a malabsortive distal RYGB, good results are not common".

To the best of our knowledge and after extensive literature search, there is no outcome study employing a laparoscopic approach for revisional malabsorptive distal Roux-en-Y gastric bypass specially increasing the restrictive component in a failed primary malabsorptive distal type of gastric bypass. Thus, we decided to analyze our own series including the learning curve and diverse revisional techniques in this unique subset of patients: 1) revision gastroplasty; 2) Fobi-Capella (static band); 3) Adjustable gastric band; 4) Conversion to either modality of malabsorptive distal gastric bypass, very, very long limb or distal.

Summarizing, there is lack of very-long term outcomes after bariatric surgery and standardization of gastric bypass surgery. The treatment of inadequate weight loss or weight recidivism after Roux-en-Y gastric bypass (RYGB) remains refractory to medical treatment. Failure rates have been reported up to 20% and 35% for the morbidly obese and super obese, respectively at 2 to 3 years after surgery. The indication for further surgical intervention remains controversial, as does what type of procedure to recommend. Furthermore, there is no standardization of the limb lengths, pouch size or the use of prosthetic reinforcement. Therefore the approach to these patients must be as individualized as their original operations. We analyze our experience with the laparoscopic approach to these complex and challenging patients.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Clinically Severe Obesity
  • Obesity Recidivism
  • Inadequate Initial Weight Loss
  • Poor Weight Loss
  • Persistent Obesity
  • Refractory Obesity
  • Intractable Obesity
Intervention Not Provided
Study Groups/Cohorts Malabsorptive distal gastric bypass
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 26, 2009)
19
Original Actual Enrollment Same as current
Actual Study Completion Date December 2009
Primary Completion Date Not Provided
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01040481
Other Study ID Numbers CMC IRB No. 2009066
U1111-1113-0500 ( Other Identifier: World Health Organization, Universal Trial Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
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
Study Sponsor University of California, San Francisco
Collaborators Not Provided
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
PRS Account University of California, San Francisco
Verification Date December 2009