Ignite Creation Date:
2024-05-05 @ 10:10 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01041131
Status:
COMPLETED
Last Update Posted:
2010-01-01
First Post:
2009-12-26
Brief Title:
Laparoscopic Revision of Vertical Banded Gastroplasty to Gastric Bypass
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Laparoscopic Revisional Gastric Bypass Surgery for Failed andor Complicated Open Vertical Banded Gastroplasty Our Experience With 70 Patients
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:
VBG
Brief Summary:
The main aim of this study is to analyze and report the intermediate term outcomes after laparoscopic revision Roux-en-Y gastric bypass RYGB surgery for failed andor complicated Vertical Banded Gastroplasty VBG 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 3 Subjective Satisfaction and Health-Related Quality of Life HR-QoL are measured by a standardized non-validated satisfaction questionnaire and by a validated disease-specific worldwide used HR-QoL questionnaire 4 Morbidity Mortality include nutritional status and metabolic complications
Consequently secondary objectives of this study are the following 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 assessed at each postoperative year after the surgery under study 2 To evaluate the metabolic and nutritional status by measurements of particular clinical and biochemical parameters
Consequently secondary objectives of this study are the following 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 assessed at each postoperative year after the surgery under study 2 To evaluate the metabolic and nutritional status by measurements of particular clinical and biochemical parameters
Detailed Description:
There is no real standardization for any of the previously stated modern standard bariatric procedures endorse by the ASMBS thus outcomes vary widely with each one of them For purposes of this study the term Vertical Banded Gastroplasty VBG is used to encompass several types of vertical gastroplasties with a reinforced stoma such as nondivided vertical banded gastroplasty nondivided vertical ringed gastroplasty transected or divided vertical ringed or banded gastroplasties among others VBG in various forms was used extensively for more than 2 decades after its original description by Mason in 198217 Designed to avoid the long-term nutritional implications and complexity of gastric bypass VBG evolved and permitted us to infer some mechanism of failure and modify other bariatric procedures Regardless of a laparoscopic approach VBG is no longer a viable option for the treatment of morbid obesity because of less overall weight loss high failure and late complication rates
The following are the main investigators that have addressed diverse revisional strategies including restoration or conversion of VBG into a modern bariatric procedure either by open or laparoscopic approach because of failure andor technical complications
I Open approach Most of the scientific literature available on redo bariatric surgery is based on open surgery series There is no consensus on what type of revisional procedure is the best however there are several options available
A Restoration or re-VBG is no longer a viable option
1 In a study of 122 gastroplasties Sugerman et al reported that four out of ten re-VBG patients required a third revision
2 With a Kaplan-Meyer analysis Van Gemert et al found that re-VBG carry a secondary revisional rate of 68 over a 5-year period vs a 0 rate after conversion to RYGB
B Other revisional option is adjustable gastric band AGB
1 In 2001 Charuzi et al described revisional adjustable gastric band after diverse failed primary bariatric procedures However they reported their compound outcome results without subset analysis
2 In the same year Taskin et al published a series of 7 patients undergoing revisional adjustable gastric banding and obtained comparable results with primary AGB at 2 years However all patients had preoperatively identified a staple-line failure and the morbi-mortality was not stated
3 In 2004 Gavert et al analyzed 47 patients undergoing laparoscopic revisional surgery using AGB with a mean BMI at 16 months of 32 and an early complication rate of 4 No mortality was reported
C Other recently added strategy to the revisional armamentarium is Sleeve Gastrectomy SG Iannelli et al in 2009 published the analysis of 41 patients undergoing revisional SG for failed AGB n36 or VBG n5 No subset analysis was provided however postoperative morbidity was 122 at a mean of 134 months mean BMI EWL and EBL were 427 427 474 respectively and re-operation rate for failure was 146 n6
D Another reported revisional procedure is Biliopancreatic Diversion with Duodenal Switch BPD-DS
1 Of 47 patients revised to BPD-DS by Keshishian et al 16 had a VBG as the primary bariatric procedure Their reported outcome data is mixed with failed RYGB n31 Although this revisional strategy carried a higher major morbidity rate 128 the weight loss was comparable to the primary BPD-DS
E However most published studies about revisional surgery for failed or complicated VBG support RYGB as a revisional procedure Previously some investigators have shown the RYGB superiority over VBG Specifically RYGB has more overall weight loss less late complications and less revision rates than VBG
1 Sugerman and van Gemert have compared restoration vs conversion to RYGB highlighting again the supremacy of RYGB mostly based on the revisional rate and weight loss Therefore conversion of VBG to RYGB seems to be logical
2 In 1993 Sapala et al n20 reported technical strategies for converting VBG to RYGB Major early morbidity occurred in 4 patients 20
3 In 1996 Sugerman et al n53 obtained a statistical significant increased of EWL from 36 to 67 and 20 to 70 in big eaters and in sweets eaters respectively Weight loss for revisional RYGB was comparable to the one after primary RYGB Upper GI symptoms were completely resolved Morbidity was described in 26 patients 49
4 In 1998 Capella Capella n60 with an adjusted Roux-limb length for BMI reported at 1 year follow-up 68 and 76 EWL for proximal and distal RYGB patients respectively
5 In 2004 Cordera et al n54 with an adjusted Roux-limb length for BMI reported weight loss as a decrease in BMI from 46 Kgm2 at the time of conversion to 35 Kgm2 at 61 years 94 patients In addition comorbidities status measured by medication consumption were ameliorated and subjective patient satisfaction at survey was high 90 However one year post-conversion 41 of the series had a BMI greater than 35 Kgm2
6 In 2005 Gonzalez et al n28 on a 5 basic steps of standardized technique and adjusted Roux-limb length for BMI reported a decrease in BMI from 40 Kgm2 to 32 Kgm2 at 16 months of follow-up Overall EWL was 48 range 3-71 however resolution in comorbidities ranged from 50 to 86 Early morbidity occurred in 9 patients 32
7 In 2007 van Dielen et al n41 revised 11 AGB and 30 VBG most of them by open approach BMI decreased from 377 to 294 at 12 months while EWL increased from 391 to 754 p 0001 Major early n4 and late n10 complications were registered No remission in comorbidities was observed35
8 In the 2007 outcome analysis by Schouten et al n101 found out that the effect on weight is dependent of the indication for revision Weight recidivism patients BMI decreased from 405 Kgm2 to 301 Kgm2 excessive weight loss patients BMI increased from 223 Kgm2 to 253 Kgm2 and adequate response patients to VBG but with severe eating difficulties remained stable 298 Kgm2 to 290 Kgm2 all after a mean follow-up of 38 months
Therefore based on all this observational studies the open conversion of VBG to RYGB has been demonstrated to be an effective procedure with defined complications
II Laparoscopic Approach Increasing experience with minimally invasive bariatric surgery has prompted surgeons to approach most revisions procedures laparoscopically
A Because most published studies about open revisional surgery for failed andor complicated VBG support RYGB as the revisional procedure of choice most laparoscopic bariatric surgeons follow this principle
1 Csepel et al n7 in 2001 reported their initial experience with laparoscopic approach for revision bariatric surgery 6 patients in this group had failed VBG Pre-revisional BMI decreased from 422 to 372 without specifying the length of follow-up or resolution of comorbidities Three major complications 428 were reported
2 Gagner et al reported their continued revisional experience with 12 patients a subgroup of 27 who underwent reoperation for failed VBG Overall pre-revisional BMI decreased from 427 Kgm2 to 359 Kgm2 after 8 months of follow-up p 0001 with a 22 complication rate Resolution of comorbidities was not stated
3 Gagne et al in 2005 reported their experience revising laparoscopically 25 patients with a 24 morbidity rate 51 EWL at 3 years 100 resolution of diabetes and 63 resolution of hypertension
4 In 2005 Calmes et al n49 reported their initial experience with laparoscopic revisional RYGB with 15 patients a subset of 49 who had a failed or complicated VBG Overall complication rate of 36 Major 4 minor 20 and late 14 70-75 of the patients at 4 years had a BMI less than 35
5 In 2007 Suter et al reported their accumulative experience with open n47 and laparoscopic n74 revisional RYGB The primary procedures were LAGB n82 VBG 36 and RYGB n3 Overall morbidity was 264 and 75 of the patients at 5 years had a BMI less than 35 Kgm2
6 Van Dessel et al in 2008 published his experience on 36 patients with laparoscopic revisional RYGB for failed restrictive procedures 14 VBG 20 AGB and 2 SG After a short follow-up of 66 months early and late morbidity was 30 and 167 respectively BMI dropped from 388 kgm2 to 309 kgm2 and a higher but not significant early morbidity rate for the complicated vs the failed subgroups
Summarizing there is lack of standardization of primary and revisional bariatric surgery compounded by a scant long-term outcome data The treatment of inadequate weight loss weight recidivism and most severe technical complications after primary bariatric surgery remains refractory to non-operative treatment Failure and secondary revisional rates after VBG can be as high as 56 and 68 respectively Indication for further surgical intervention remains controversial as does what type of procedure to recommend but the most widely documented and with best risk-benefit ratio option is RYGB After extensive literature search there is no outcome study employing a laparoscopic revisional strategy with a HSA reporting outcomes comparable to primary gastric bypass in an unselected obese population Thus we formally analyze our experience with the laparoscopic approach to these complex and challenging patients
The following are the main investigators that have addressed diverse revisional strategies including restoration or conversion of VBG into a modern bariatric procedure either by open or laparoscopic approach because of failure andor technical complications
I Open approach Most of the scientific literature available on redo bariatric surgery is based on open surgery series There is no consensus on what type of revisional procedure is the best however there are several options available
A Restoration or re-VBG is no longer a viable option
1 In a study of 122 gastroplasties Sugerman et al reported that four out of ten re-VBG patients required a third revision
2 With a Kaplan-Meyer analysis Van Gemert et al found that re-VBG carry a secondary revisional rate of 68 over a 5-year period vs a 0 rate after conversion to RYGB
B Other revisional option is adjustable gastric band AGB
1 In 2001 Charuzi et al described revisional adjustable gastric band after diverse failed primary bariatric procedures However they reported their compound outcome results without subset analysis
2 In the same year Taskin et al published a series of 7 patients undergoing revisional adjustable gastric banding and obtained comparable results with primary AGB at 2 years However all patients had preoperatively identified a staple-line failure and the morbi-mortality was not stated
3 In 2004 Gavert et al analyzed 47 patients undergoing laparoscopic revisional surgery using AGB with a mean BMI at 16 months of 32 and an early complication rate of 4 No mortality was reported
C Other recently added strategy to the revisional armamentarium is Sleeve Gastrectomy SG Iannelli et al in 2009 published the analysis of 41 patients undergoing revisional SG for failed AGB n36 or VBG n5 No subset analysis was provided however postoperative morbidity was 122 at a mean of 134 months mean BMI EWL and EBL were 427 427 474 respectively and re-operation rate for failure was 146 n6
D Another reported revisional procedure is Biliopancreatic Diversion with Duodenal Switch BPD-DS
1 Of 47 patients revised to BPD-DS by Keshishian et al 16 had a VBG as the primary bariatric procedure Their reported outcome data is mixed with failed RYGB n31 Although this revisional strategy carried a higher major morbidity rate 128 the weight loss was comparable to the primary BPD-DS
E However most published studies about revisional surgery for failed or complicated VBG support RYGB as a revisional procedure Previously some investigators have shown the RYGB superiority over VBG Specifically RYGB has more overall weight loss less late complications and less revision rates than VBG
1 Sugerman and van Gemert have compared restoration vs conversion to RYGB highlighting again the supremacy of RYGB mostly based on the revisional rate and weight loss Therefore conversion of VBG to RYGB seems to be logical
2 In 1993 Sapala et al n20 reported technical strategies for converting VBG to RYGB Major early morbidity occurred in 4 patients 20
3 In 1996 Sugerman et al n53 obtained a statistical significant increased of EWL from 36 to 67 and 20 to 70 in big eaters and in sweets eaters respectively Weight loss for revisional RYGB was comparable to the one after primary RYGB Upper GI symptoms were completely resolved Morbidity was described in 26 patients 49
4 In 1998 Capella Capella n60 with an adjusted Roux-limb length for BMI reported at 1 year follow-up 68 and 76 EWL for proximal and distal RYGB patients respectively
5 In 2004 Cordera et al n54 with an adjusted Roux-limb length for BMI reported weight loss as a decrease in BMI from 46 Kgm2 at the time of conversion to 35 Kgm2 at 61 years 94 patients In addition comorbidities status measured by medication consumption were ameliorated and subjective patient satisfaction at survey was high 90 However one year post-conversion 41 of the series had a BMI greater than 35 Kgm2
6 In 2005 Gonzalez et al n28 on a 5 basic steps of standardized technique and adjusted Roux-limb length for BMI reported a decrease in BMI from 40 Kgm2 to 32 Kgm2 at 16 months of follow-up Overall EWL was 48 range 3-71 however resolution in comorbidities ranged from 50 to 86 Early morbidity occurred in 9 patients 32
7 In 2007 van Dielen et al n41 revised 11 AGB and 30 VBG most of them by open approach BMI decreased from 377 to 294 at 12 months while EWL increased from 391 to 754 p 0001 Major early n4 and late n10 complications were registered No remission in comorbidities was observed35
8 In the 2007 outcome analysis by Schouten et al n101 found out that the effect on weight is dependent of the indication for revision Weight recidivism patients BMI decreased from 405 Kgm2 to 301 Kgm2 excessive weight loss patients BMI increased from 223 Kgm2 to 253 Kgm2 and adequate response patients to VBG but with severe eating difficulties remained stable 298 Kgm2 to 290 Kgm2 all after a mean follow-up of 38 months
Therefore based on all this observational studies the open conversion of VBG to RYGB has been demonstrated to be an effective procedure with defined complications
II Laparoscopic Approach Increasing experience with minimally invasive bariatric surgery has prompted surgeons to approach most revisions procedures laparoscopically
A Because most published studies about open revisional surgery for failed andor complicated VBG support RYGB as the revisional procedure of choice most laparoscopic bariatric surgeons follow this principle
1 Csepel et al n7 in 2001 reported their initial experience with laparoscopic approach for revision bariatric surgery 6 patients in this group had failed VBG Pre-revisional BMI decreased from 422 to 372 without specifying the length of follow-up or resolution of comorbidities Three major complications 428 were reported
2 Gagner et al reported their continued revisional experience with 12 patients a subgroup of 27 who underwent reoperation for failed VBG Overall pre-revisional BMI decreased from 427 Kgm2 to 359 Kgm2 after 8 months of follow-up p 0001 with a 22 complication rate Resolution of comorbidities was not stated
3 Gagne et al in 2005 reported their experience revising laparoscopically 25 patients with a 24 morbidity rate 51 EWL at 3 years 100 resolution of diabetes and 63 resolution of hypertension
4 In 2005 Calmes et al n49 reported their initial experience with laparoscopic revisional RYGB with 15 patients a subset of 49 who had a failed or complicated VBG Overall complication rate of 36 Major 4 minor 20 and late 14 70-75 of the patients at 4 years had a BMI less than 35
5 In 2007 Suter et al reported their accumulative experience with open n47 and laparoscopic n74 revisional RYGB The primary procedures were LAGB n82 VBG 36 and RYGB n3 Overall morbidity was 264 and 75 of the patients at 5 years had a BMI less than 35 Kgm2
6 Van Dessel et al in 2008 published his experience on 36 patients with laparoscopic revisional RYGB for failed restrictive procedures 14 VBG 20 AGB and 2 SG After a short follow-up of 66 months early and late morbidity was 30 and 167 respectively BMI dropped from 388 kgm2 to 309 kgm2 and a higher but not significant early morbidity rate for the complicated vs the failed subgroups
Summarizing there is lack of standardization of primary and revisional bariatric surgery compounded by a scant long-term outcome data The treatment of inadequate weight loss weight recidivism and most severe technical complications after primary bariatric surgery remains refractory to non-operative treatment Failure and secondary revisional rates after VBG can be as high as 56 and 68 respectively Indication for further surgical intervention remains controversial as does what type of procedure to recommend but the most widely documented and with best risk-benefit ratio option is RYGB After extensive literature search there is no outcome study employing a laparoscopic revisional strategy with a HSA reporting outcomes comparable to primary gastric bypass in an unselected obese population Thus we formally 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 |
|---|---|---|---|
| U1111-1113-0085 | OTHER | World Health Organization Universal Trial Number | None |