Laparoscopic Revision of Vertical Banded Gastroplasty to Gastric Bypass
Condition: Clinically Severe Obesity; Inadequate Weight Loss; Obesity Recidivism
MeSH terms: Obesity; Obesity, Morbid; Weight Loss
Study type: Observational

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.
    

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)
      
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