E. McLaughlin, P. D. Chakravarty, D. Whittaker, E. Cowan, K. Xu, E. Byrne, D.M. Bruce, J. A. Ford University of Aberdeen

Contents Background Objectives Methodology Results Discussion Other Considerations Conclusions

Obesity- A Growing Problem The Scottish Government. The Scottish Health Survey. Volume 1: chapter 7; Adult obesity; 7:

Obesity- Cost Costs NHS Scotland £171 million annually Main risk factor for diabetes and cardiovascular disease Current management involves lifestyle and behavioural interventions

Bariatric Surgery Number of bariatric procedures performed in the UK is increasing. 3 types of procedure:  Restrictive - Gastric banding, Sleeve gastrectomy, Vertical banded gastroplasty (VBG)  Malabsorptive - Duodenal switch, Biliopancreatic diversion  Malabsorptive and Restrictive -Gastric bypass Laparoscopic adjustable gastric banding (LAGB) represents 30.3% of bariatric procedures

SIGN Guidelines Recommends bariatric surgery for patients who:  Have a BMI > 35  Have one or more co-morbidities expected to improve with weight loss  Have completed a weight management program with no improvement in co-morbidities No recommendations on procedure

Objective Examine evidence for the effectiveness of LAGB compared with other bariatric procedures

Methodology A systematic review of RCTs was performed in accordance with the PRISMA statement. Inclusion criteria - All RCTs comparing LAGB and other surgical procedures Exclusion criteria - Non-adult studies, open gastric banding procedures and trials that reported surrogate end points Primary Outcomes - Co-morbidity improvement Secondary Outcomes – QOL improvement, mean change in BMI or percentage excess weight loss (%EWL), complications, length of hospital stay and operation time

Methodology Databases used - MEDLINE, EMBASE, CENTRAL and clinicaltrials.gov Studies included from June 2011 Literature search performed by 2 authors independently Data extracted by one author and checked by second Study quality was assessed using Cochrane risk of bias criteria

The Trials Literature search uncovered 801 studies 5 RCTs (7 published articles) included Trials carried out between 2003 and 2010 Comparative surgeries:  Laparoscopic roux-en-Y gastric bypass (LRYGB)  Vertical banded gastroplasty (VBG)  Sleeve gastrectomy (SG) Follow up ranged from 6 months to 7 years The largest sample size was 197 and the smallest was 51 Baseline characteristics were comparable throughout

Effect on Co-morbidities Poor reporting of co-morbidities Van Dielen 2004  Sample size of 100  Number of co-morbidities in both LAGB and VBG groups decreased  No difference between groups  Co-morbidities had increased at 7 year follow up (10% of the LAGB group and 0% of the VBG suffered from diabetes) Angrisani 2007  Sample size of 51  Co-morbidities had resolved after 5 years in both LAGB and LRYGB groups (only 4 patients in each group)

QOL Poor reporting of QOL Nguyen 2009  Sample size of 197  Improvement of QOL 12 months post surgery  Did not differ significantly between arms  Time to resume normal daily activities and time to return to work were both significantly increased with LRYGB compared to LAGB.

Weight Loss Mean reduction in BMI and % EWL greater in the non LAGB arms in all 5 studies Statistically significant Greatest weight loss in first post-operative year Weight loss negligible beyond three years

Operative time and length of hospital stay Operative time  Mean operative time was shorter in the LAGB group in each trial Hospital Stay  Mean hospital stay was shorter in the LAGB group in each trial

Complications Early complications  Lower incidence of early complications in the LAGB arm Late complications  Evidence conflicted  Two trials reported a decrease in late complications in LAGB compared with other procedures (one significant)  Two trials reported increase in late complications in LAGB compared with other procedures (one significant)

Study Quality Two studies failed to report sequence generation Two studies failed to describe method of allocation concealment No studies adequately described blinding Up to 20% lost to follow up

Strengths and Limitations Strength  Only level 1 studies used  Robust literature search  Careful data extraction  Consistent baseline characteristics  Study design and primary outcome similar throughout studies Limitations  Only involved comparisons with LRYGB, SG and VBG  No meta-analysis

Limitations of Evidence Base Lack of trials  Only 5 trials  Only 2 assessing Co-morbidities  Only 1 assessing QOL RCTs flawed  Small sample sizes  Missing data  Lack of blinding (blinding assessors)  No expertise based randomization model used

Interpretation of Results Reduction in co-morbidities similar between groups Increased QOL similar between groups Change in mean BMI and %EWL was superior in all comparative surgeries Operative time and hospital stay are considerably longer in the LRYGB, SG and VBG groups Early complications were more frequent in the comparative surgeries than LAGB Evidence on late complications is unclear

Other Considerations Cost  VBG, LRYGB and LAGB were found to be cost effective when compared with no treatment  Economic analysis does not appear to strongly support one procedure over another Patient Choice  Patients often feel strongly about the choice of procedures

Conclusions Data on co-morbidity reduction and QOL improvement lacking LAGB may not be the most effective procedure in terms of weight loss Fewer complications and shorter operation time and hospital stay may counteract this Current evidence base is limited Surgery should be tailored to the patient’s own choice and health status