CONTEXT
Use of bariatric surgery for severe obesity has increased dramatically.
OBJECTIVE
To systematically review 1. the clinical efficacy and safety, 2. cost-effectiveness of bariatric surgery, and 3. the association
between number of surgeries performed (surgical volume) and outcomes.
DATA SOURCES
MEDLINE (from 1950), EMBASE (from 1980), CENTRAL, EconLit, EURON EED, Harvard Center for Risk Analysis, trial registries and
HTA websites were searched to January 2011.
STUDY SELECTION
1. Randomized controlled trials (RCTs) and 2. cost-utility and cost-minimisation studies comparing a contemporary bariatric
surgery (i.e., adjustable gastric banding, Roux-en-Y gastric bypass, sleeve gastrectomy) to another contemporary surgical
comparator or a non-surgical treatment or 3. Any study reporting the association between surgical volume and outcome.
DATA EXTRACTION
Outcomes included changes in weight and obesity-related comorbidity, quality of life and mortality, surgical complications,
resource utilization, and incremental cost-utility.
RESULTS
RCT data evaluating mortality and obesity-related comorbidity endpoints were lacking. A small RCT of 16 patients reported
that adjustable gastric banding reduced weight by 27% (p < 0.01) compared to diet-treated controls over 40 weeks. Six small RCTs reported comparisons of commonly used, contemporary
procedures. Gastric banding reduced weight to a lower extent than gastric bypass and sleeve gastrectomy and resulted in shorter
operating times, fewer serious complications, lower weight loss efficacy, and more frequent reoperations compared to gastric
bypass. Sleeve gastrectomy and gastric bypass reduced weight to a similar extent. A 2-year RCT in 50 adolescents reported
that gastric banding substantially reduced weight compared to lifestyle modification (35 kg vs. 3 kg; p <0.001). Based on findings of 14 observational studies, higher volume centers and surgeons had lower mortality and complication
rates. Surgery resulted in long-term incremental cost–utility ratios of $ <1.000–$ <1.000–40,000 (2009 USD) per quality-adjusted-life-year
compared with non-surgical treatment.
CONCLUSIONS
Contemporary bariatric surgery appears to result in sustained weight reduction with acceptable costs but rigorous, longer-term
(≥5 year) data are needed and a paucity of RCT data on mortality and obesity related comorbidity is evident. Procedure-specific
variations in efficacy and risks exist and require further study to clarify the specific indications for and advantages of
different procedures.
KEY WORDS randomized controlled trials – clincical evidence – economic evidence – systematic review