Ignite Creation Date:
2024-05-05 @ 10:10 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01040481
Status:
COMPLETED
Last Update Posted:
2009-12-29
First Post:
2009-12-26
Brief Title:
Adding Malabsorption for Failed Gastric Bypass
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Laparoscopic Revisional Surgery Adding Malabsorption for Failed Gastric Bypass
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 andor lack of resolutionimprovement 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
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 andor lack of resolutionimprovement 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 205000 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 kgm2 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 kgm2 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 905 follow-up rate Analyzed traditional outcome measures were early 21 and late 27 morbidity including protein-calorie malnutrition 7 EWL at 1234and 5 years were 895 91 87 825 825 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 n80 followed for 3 years with a 925 follow-up rate Reported traditional outcome measures were early 39 and late 84 morbidity EWL at 123 years was 83 89and 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 Sapalas 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 686 766 and 723 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 697 650 748 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 74 n4 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 479 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
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 kgm2 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 kgm2 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 905 follow-up rate Analyzed traditional outcome measures were early 21 and late 27 morbidity including protein-calorie malnutrition 7 EWL at 1234and 5 years were 895 91 87 825 825 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 n80 followed for 3 years with a 925 follow-up rate Reported traditional outcome measures were early 39 and late 84 morbidity EWL at 123 years was 83 89and 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 Sapalas 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 686 766 and 723 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 697 650 748 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 74 n4 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 479 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1113-0500 | OTHER | World Health Organization Universal Trial Number | None |