Seven-year outcomes from the SLEEVE vs byPASS (SLEEVEPASS) randomised clinical trial has reported that laparoscopic Roux-en-Y gastric bypass resulted in greater weight loss than laparoscopic sleeve gastrectomy LSG however, the difference was not clinically relevant based on the prespecified equivalence margins. Interestingly, there was no difference in long-term quality of life (QoL) between the procedures, and surgery was associated with significant long-term Disease-specific QoL (DSQoL) improvement, with greater weight loss was associated with better DSQoL.
The results were featured in the paper, ‘Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass on Weight Loss and Quality of Life at 7 Years in Patients With Morbid Obesity The SLEEVEPASS Randomized Clinical Trial’, published in JAMA Surgery.
SLEEVEPASS was established to examine whether weight loss equivalence and improvement of quality of life similar at seven years after LSG (n=121) and LRYGB (n=119) in 240 patients with morbid obesity with special reference to long-term QoL.
The multi-centre, multi-surgeon, open-label, randomised clinical equivalence trial was conducted between March 2008, and June 2010, in Finland (last follow-up, September 2017). Analysis was conducted on an intention-to-treat basis. Statistical analysis was performed from June 2018, to November 2019.
The primary end point was percentage excess weight loss (%EWL) at five years and the secondary predefined follow-up time points were seven, ten, 15 and 20 years, with included seven-year secondary end points of QoL and morbidity. Disease-specific QoL (Moorehead-Ardelt Quality of Life questionnaire [range of scores, –3 to 3 points, where a higher score indicates better QoL]) and general health-related QoL (HRQoL; 15D questionnaire [0-1 scale for all 15 dimensions, with 1 indicating full health and 0 indicating death]) were measured preoperatively and at one, three, five, and seven years postoperatively concurrently with weight loss.
The majority of patients were female (167), the mean age was 48.4 years and mean baseline body mass index was 45.9. A total of 182 (75.8%) completed the seven-year follow-up. At seven years, the mean %EWL was 47% after LSG and 55% after LRYGB, the mean DSQoL total score at was 0.50 (1.14) after LSG and 0.49 (1.06) after LRYGB (p=0.63) and the median HRQoL total score was 0.88 after LSG and 0.87 (after LRYGB (p=0.37).
At seven years, mean DSQoL scores improved significantly compared with baseline (LSG, 0.50 [1.14] vs 0.10 [0.94]; and LRYGB, 0.49 [1.06] vs 0.12 [1.12]; p<0.001), unlike median HRQoL scores (LSG, 0.88 [IQR, 0.78-0.95] vs 0.87 [IQR, 0.78-0.90]; and LRYGB, 0.87 [IQR, 0.78-0.92] vs 0.85 [IQR, 0.77-0.91]; p=0.07). The overall morbidity rate was 24.0% (29 of 121) for LSG and 28.6% (34 of 119) for LRYGB (p=0.42).
The authors noted that as the seven-year mean percentage excess weight loss was 47% after LSG vs 55% after LRYGB, this difference that did not meet prespecified criteria for equivalence. Interestingly, greater weight loss was associated with better DSQoL (p<0.001) and disease-specific quality of life and general quality of life were similar.