In this randomized clinical trial, RYGB led to significantly higher %EBMIL in the PP population compared to SG beyond 10 years’ follow-up. Improvement of comorbidities was similar except for GERD, which seems to be better controlled by RYGB. Patients undergoing SG experienced a significantly higher number of conversions to different anatomy compared to RYGB. The findings were reported in the paper, ‘Long-Term Outcomes of Laparoscopic Roux-en-Y Gastric Bypass vs Laparoscopic Sleeve Gastrectomy for Obesity - The SM-BOSS Randomized Clinical Trial’, published in JAMA Surgery.
The five-year results of the SM-BOSS trial published in 2018 did not show a significant difference in excess body mass index loss between SG and RYGB and in reoperation rates. This paper reports on the same cohort and provides further long-term results of SG vs RYGB and addresses weight loss, the evolution of obesity-associated comorbidities, reoperation rates and quality of life.
A total of 217 participants were included and randomised to undergo either laparoscopic SG or proximal RYGB, 107 patients underwent SG and 110 patients underwent RYGB. At ten years or more, 142 patients of the initially available 217 patients (65.4%) were available for follow-up - 69 patients (64.5%) in the SG group and 73 (66.4%) in the RYGB group, respectively.
Outcomes
Compared to baseline, mean (SD) BMI was significantly lower at ten years for both SG (33.5 [5.5]; p<0.001) and RYGB (32.0 [6.3]; p<0.001), the mean (SD) %EBMIL for the ITT population was 60.6% (25.9) after SG and 65.2% (26.0) after RYGB (p=0.29) and the mean (SD) %TWL for the ITT population was 26.3% (13.6) for SG and 27.5% (10.6) for RYGB. However, the per protocol analyses of %EBMIL showed significantly higher differences between the groups (p=0.048), with a mean (SD) %EBMIL of 56.1% (25.2) for SG and 65.9% (26.3) for RYGB.
At baseline, 18 patients in the SG group (26.1%) and 14 patients in the RYGB group (19.2%) had T2DM. Ten years or more after surgery, complete remission of T2DM was seen in 11 patients after SG (61.1%) and in ten patients after RYGB (71.4%) (absolute difference, 10.3%; 95% CI, −49.7 to 34.3%; p=0.71).
Prior to surgery, 42 patients in the SG group (60.9%) and 31 patients in the RYGB group (42.5%) had dyslipidaemia. Complete remission was seen in 13 of 42 patients in the SG group (31.0%) vs 6 of 31 patients in the RYGB group (19.4%) ten years or more after surgery (absolute difference, 11.6; 95% CI, −17.2 to 36.8; p=0.72).
At the time of surgery, 25 of 69 patients in the SG group (36.2%) and 32 of 73 patients in the RYGB group (43.8%) had some degree of GERD. Beyond ten years, remission of reflux symptoms was seen in 17 of 25 patients in the SG group (68.0%) and 23 of 32 patients in the RYGB group (71.9%). However, 11 of 34 patients who had no GERD at baseline (32.3%) reported de novo reflux symptoms at ten years after SG, in contrast to in three of 38 patients who underwent RYGB (7.9%) (p=0.02).
The overall complications were not significantly different between the groups, with mean (SD) comprehensive complication index (CCI) scores of 13.0 (19.3) for the SG group and 12.0 (31.3) for the RYGB group. The CCI score was greater than 0 in 32 of 107 patients in the SG group (29.9%) and in 21 of 110 patients in the RYGB group (19.1%) (p=0.08). For those patients with a CCI score greater than 0, the severity of complications was not significantly different between groups (mean [SD] severity, SG: 38.1 [20.5] vs RYGB: 38.2 [20.4]; p=0.99).
However, patients after SG had significantly higher conversion rates because of suboptimal clinical response or GERD compared to RYGB (SG: 32 of 107 patients [29.9%] vs RYGB: 6 of 110 patients [5.5%]; p<0.001). Reasons for conversion in the SG group were reflux (15 of 32 [46.9%]), suboptimal weight loss (9 [28.1%]), a combination of both factors (6 [18.8%]) or strictures (2 [6.3%]). Reasons for conversion or revision in the RYGB group were all because of suboptimal weight loss (6 patients).
All-cause mortality was 1 of 107 patients in the SG group (0.9%) and 5 of 110 patients in the RYGB group (4.5%) (p=0.21). Procedure-related mortality was 0 in the SG group and 1 of 110 in the RYGB group (0.9%).
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