Clinical trial NCT01041131: Laparoscopic Revision of Vertical Banded Gastroplasty to Gastric Bypass
Official title: Laparoscopic Revisional Gastric Bypass Surgery for Failed and/or Complicated Open Vertical Banded Gastroplasty: Our Experience With 70 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinically Severe Obesity
Inadequate Weight Loss
Obesity Recidivism
Keywords: Obesity
Obesity recidivism
Inadequate Initial Weight Loss
Technical bariatric complications
Complicated gastroplasty
Failed gastroplasty
Gastroesophageal reflux disease
Revisional gastric bypass
Conversion bariatric surgery
Re-operative bariatric surgery
Technical complications of vertical gastroplasty
Complicated vertical gastroplasty
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-12-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients status post failed and/or complicated Vertical Banded Gastroplasty (VBG) undergoing conversion to laparoscopic Roux-en-Y gastric bypass (RYGB)

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 and/or 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, and/or %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), and/or lack of resolution/improvement 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 and/or 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 (n=36) or VBG (n=5). No subset analysis was provided however postoperative morbidity was 12.2%; at a mean of 13.4 months, mean BMI, %EWL, and %EBL were 42.7%, 42.7%, 47.4% respectively; and re-operation rate for failure was 14.6% (n=6).

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 (n=31). Although this revisional strategy carried a higher major morbidity rate (12.8%), 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 (n=20) reported technical strategies for converting VBG to RYGB. Major early morbidity occurred in 4 patients (20%).
3. In 1996, Sugerman et al (n=53) 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 (n=60), 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 (n=54), with an adjusted Roux-limb length for BMI, reported weight loss as a decrease in BMI from 46 Kg/m2, at the time of conversion, to 35 Kg/m2 at 6.1 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 Kg/m2.
6. In 2005, Gonzalez et al (n=28), on a 5 basic steps of standardized technique and adjusted Roux-limb length for BMI, reported a decrease in BMI from 40 Kg/m2 to 32 Kg/m2 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 (n=41) revised 11 AGB and 30 VBG most of them by open approach. BMI decreased from 37.7 to 29.4 at 12 months while %EWL increased from 39.1% to 75.4% (p\< 0.001). Major early (n=4) and late (n=10) complications were registered. No remission in comorbidities was observed35.
8. In the 2007 outcome analysis by Schouten et al (n=101) found out that the effect on weight is dependent of the indication for revision. Weight recidivism patient's BMI decreased from 40.5 Kg/m2 to 30.1 Kg/m2; excessive weight loss patients BMI increased from 22.3 Kg/m2 to 25.3 Kg/m2; and adequate response patients to VBG but with severe eating difficulties remained stable (29.8 Kg/m2 to 29.0 Kg/m2) 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 and/or complicated VBG support RYGB as the revisional procedure of choice, most laparoscopic bariatric surgeons follow this principle.

1. Csepel et al (n=7), 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 42.2 to 37.2 without specifying the length of follow-up or resolution of comorbidities. Three major complications (42.8%) 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 42.7 Kg/m2 to 35.9 Kg/m2 after 8 months of follow-up (p\< 0.001) 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 (n=49) 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 (n=47) and laparoscopic (n=74) revisional RYGB. The primary procedures were LAGB (n=82), VBG (36) and RYGB (n=3). Overall morbidity was 26.4% and 75% of the patients at 5 years had a BMI less than 35 Kg/m2.
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 6.6 months, early and late morbidity was 30% and 16.7%, respectively; BMI dropped from 38.8 kg/m2 to 30.9 kg/m2; 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.

Eligibility criteria: Inclusion Criteria:

* Patients status post failed and/or complicated VBG undergoing laparoscopic revisional RYGB

Exclusion Criteria:

* Patients with prior major conversion, revision, and/or esophago-gastric surgery
* Conversion performed by open approach
* Conversion performed somewhere else with follow-up by our program

Primary outcomes:
measure: Morbidity and mortality
timeFrame: at discharge, 1 week, 3 weeks, 8 weeks, 3 months, 6 months, 1 year and annually thereafter for up to 8 years
measure: Weight loss expressed as Body Mass Index and Percentage excess weight loss
timeFrame: at 6 months, 1 year and annually thereafter for up to 8 years
measure: Remission or improvement of symptoms
timeFrame: at 6 months, 1 year and annually thereafter for up to 8 years
Secondary outcomes:
measure: Length of operative time which is defined as the time duration of operation measured in minutes from the first skin incision to the final closure of the skin incision
timeFrame: It is measured in minutes from the first skin incision to the final closure of the skin incision at the time of revisional surgery under study. It is a transoperative measure of outcome of the surgery under study
measure: Remission or improvement of comorbidities
timeFrame: at 6 months, 1 year, and annually thereafter for up to 8 years
measure: Length of Hospital Stay which is a measured of surgical recovery quantified and reported in days. It is a hospital pre-discharge traditional measure of outcome.
timeFrame: It is measured in days from the admission date to the discharge date for the hospitalization pertaining to revisional surgery under study.
Other outcomes:
Locations:
city: Fresno
country: United States
facility: UCSF Fresno Center for Medical Education and Research
state: California
Study officials:
affiliation: Research Associate, University of California San Francisco
name: Francisco M Tercero, MD
role: STUDY_DIRECTOR
affiliation: Professor of Surgery, University of California San Francisco
name: Kelvin D Higa, MD
role: PRINCIPAL_INVESTIGATOR
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