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SM-BOSS and SLEEVEPASS

Two RCTs show little difference between RYGB and LSG at five years

No significant difference in regard to excess BMI loss between the two procedures, although in both trials RYGB did result in greater percentage excess BMI loss

The five-year outcomes from two randomised clinical trials both assessing sleeve gastrectomy (LSG) vs laparoscopic Roux-en-y gastric bypass (RYGB), have concluded that there is no significant difference in regard to excess BMI loss between the two procedures, although in both trials RYGB did result in greater percentage excess BMI loss.

In the first paper, ‘Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity - The SM-BOSS Randomized Clinical Trial’, published in JAMA, researchers presented the five year results from the Swiss Multicenter Bypass Or Sleeve Study (SM-BOSS). This clinical trial was designed to determine whether there are differences between LSG and RYGB in terms of weight loss (primary outcome), as well as changes in comorbidities, increase in quality of life and adverse events. SM-BOSS recruited 217 patients who were randomly assigned to undergo LSG (n=107) or laparoscopic RYGB (n=110).

At five years, 205 (94.5%) patients completed the trial and excess BMI loss was 61.1% for LSG vs 68.3% for RYGB (p=0.22) and therefore not significantly different at five years. The outcomes also revealed gastric reflux remission was more frequent in the bypass group (60.4%) compared with LSG (25.0%). Indeed, gastric reflux worsened more often after LSG (31.8%) than after RYGB (6.3%). However, the number of patients with re-operations or interventions was lower after LSG (16/101, 15.8%) compared with RYGB (23/104, 22.1%).

SLEEVEPASS study

In the second paper, ‘Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity - The SLEEVEPASS Randomized Clinical Trial’, also published in JAMA, researchers from Finland presented the five year results from the Sleeve vs Bypass (SLEEVEPASS) study.

The SLEEVEPASS study, undertaken to determine whether LSG and laparoscopic RYGB are equivalent for weight loss at five years in patients with morbid obesity, enrolled 240 morbidly obese patients aged 18 to 60 years, who were randomly assigned to LSG (n=121) or laparoscopic RYGB (n=119).

The primary end point was weight loss evaluated by percentage excess weight loss with prespecified equivalence margins for the clinical significance of weight loss differences between the procedures of −9% to +9% excess weight loss. Secondary outcomes included resolution of comorbidities, improvement of quality of life (QOL), all adverse events (overall morbidity) and mortality.

At five years, 193 (80.4%) patients were available for follow-up and estimated mean percentage excess weight loss at five years was 49% in the LSG group and 57% in the RYGB group (difference, 8.2 percentage units, and therefore did not meet criteria for equivalence.

At baseline, 42.1% of patients had type 2 diabetes, 34.6% dyslipidaemia and 70.8% hypertension. At five years, complete or partial remission of type 2 diabetes was seen in 37% (n=15/41) of patients in the LSG group and in 45% (n=18/40) of patients in the RYGB group (p>0.99). Medication for dyslipidemia was discontinued in 47% (n=14/30) after LSG and 60% (n=24/40) after gastric bypass (p=0.15) and for hypertension in 29% (n=20/68) and 51% (n= 7/73) (p=0.02), respectively.

In addition, there was no statistically significant difference in QOL between groups (p=0.85) and no treatment-related mortality. At five years the overall morbidity rate was 19% (n=23) for sleeve gastrectomy and 26% (n=31) for gastric bypass (p=0.19).

“Among patients with morbid obesity, use of LSG compared with use of laparoscopic RYGB did not meet criteria for equivalence in terms of percentage excess weight loss at five years,” the paper concluded. “Although gastric bypass compared with sleeve gastrectomy was associated with greater percentage excess weight loss at five years, the difference was not statistically significant, based on the prespecified equivalence margins.”

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