Laparoscopic vertical sleeve gastrectomy vs. Laparoscopic Roux-en Y Gastric Bypass for the treatment of obesity

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; GARCIA MARTI, S.; ALCARAZ, A.; GLUJOVSKY, D.; LOPEZ, A.; REY-ARES, L.; BARDACH, A.; CIAPPONI, A; OUBIÑA, M

Documento de Evaluación de tecnologías Sanitarias

IECS

Año: 2013 p. 1 - 30

1668-2793

In Argentina, 18% of the population is obese and 3.5% has severe or very severe obesity. The WHO defines obesity as a Body Mass Index (BMI) over 30 kg/m², severe obesity, over 35 kg/m² and very severe obesity over 40 kg/m ².Patients with severe and very severe obesity undergoing non-surgical treatment frequently re-gain the lost weight. In these cases, surgical treatment has demonstrated to be efficient to achieve long-term weight loss and improve comorbidities with the consequent decrease in overall mortality and mortality due to a specific cause.Surgical techniques aim at reducing the stomach size (adjustable gastric banding and laparoscopic vertical sleeve gastrectomy ?LVSG) and/or generating malabsorption (biliopancreatic diversion). Laparoscopic Roux-en-Y gastric bypass (LGB) is a mixed technique that is currently the gold standard. Its adverse effects are malabsorption of several nutrients and rapid gastric emptying syndrome. Both LGB and adjustable banding are included in the Mandatory Medical Plan for the treatment of obesity.Since LVSG would not present the malabsorption adverse effect LGB has, and because its technique is simpler and less invasive, it is proposed as an alternative for the treatment of severe obesity.TechnologyLVSG or sleeve gastrectomy consists in resecting great part of the greater stomach curvature, thus achieving a 25% reduction in the original gastric capacity and preserving access to the pylorus, duodenum and ampulla of Vater. It is an irreversible laparoscopic technique which allows turning into an LGB surgery, if required.PurposeTo assess the available evidence on the efficacy, safety and coverage related aspects regarding the use of LVSG in patients with obesity.MethodsA bibliographic search was carried out on the main data bases (such as MEDLINE, Cochrane and CRD), in general Internet engines, in health technology assessment agencies and health sponsors. Priority was given to the inclusion of systematic reviews; controlled, randomized clinical trials (RCTs); health technology assessments and economic evaluations; clinical practice guidelines and coverage policies of other health systems.ResultsIn this report two systematic reviews, two RCTs, four clinical practice guidelines, four health technology assessments and eleven coverage policies from health sponsors were included.In 2012, a meta-analysis was published, including four RCTs, five cohort studies, six case-control cases and one case series. It evaluated 2,758 patients with an average BMI of 43 kg/m² and a 12-month follow-up. Of these, 1,592 underwent LGB and 1,166, LVSG. LVSG was inferior to LGB in achieving diabetes mellitus control (49.11% vs. 70.83%; OR 2.46 95%CI 1.48 ? 4.09) as well as in the extent of weight loss (rate of excess weight loss is 61.67% vs. 72.34%; mean difference 10.68% 95%CI 4.60%-16.75%).In 2013, another meta-analysis was published comparing LVSG vs. LGB. It included six RCTs and two case and control studies. It evaluated 284 patients with an average BMI of 41.8 kg/m² for an average 13-month follow-up period. LVSG had less efficacy achieving a BMI loss (mean BMI difference 1.84 kg/m²; 95%CI 0.50 to 3.18) and achieving a decrease in insulin-resistance level (mean difference in the HOMA index of 0.83; 95 %CI 1.43-0.22). It also had less efficacy in improving the lipid profile, showing less total cholesterol decrease (mean difference 17.43 mg/dL, 95 %CI 34.72-0.14) and less HDL cholesterol increase (mean difference 3.27mg/dL; 95 %CI 0.48?6.06).The clinical practice guidelines consider this technique less effective than LGB, but more effective than adjustable gastric banding.Regarding health technology assessments, they coincide that the evidence comparing LVSG vs. LGB is limited; taking into account that the effectiveness of the technology and its complication rate are comparable to those of LGB.As regards, health Sponsor?s coverage policies, they agree to cover both techniques in adult patients with a BMI over 40 kg/m², or else, over 35 kg/m² with obesity associated comorbidities. Some offer coverage to teenagers with a BMI over 40 kg/m² who have associated comorbidities and have completed the bone growth process.ConclusionsThere is high quality evidence showing that LVSG is effective in achieving weight loss, improving diabetes mellitus, insulin-resistance levels and lipid profile, being slightly inferior to LGB.Because these differences are non significant, the clinical practice guidelines and health technology assessments consider this technology similar to LGB for the treatment of obesity. Health insurance companies consider its coverage for the same indications as for LGB.