SLEEVEPASS: Greater %EWL at ten years after LRYGB vs LSG
Ten-year outcomes from the SLEEVEPASS Randomized Clinical Trial - a study comparing the long-term outcomes of weight loss and remission of obesity-related comorbidities after laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) - has reported %EWL was greater after LRYGB compared with LSG, and the procedures were not equivalent for weight loss at ten years.
The study, which also examined the prevalence of gastroesophageal reflux symptoms (GERD), endoscopic esophagitis, and Barrett oesophagus (BE), found that cumulative incidence of BE was markedly lower than in previous trials and similar after both procedures, but endoscopic esophagitis, GERD symptoms, and PPI use were more prevalent after LSG, underlining the importance of preoperative GERD assessment and patient selection. In addition, there was no statistically significant difference in type 2 diabetes, dyslipidaemia, and obstructive sleep apnoea, but LRYGB resulted in superior remission of hypertension.
The findings were reported in the paper, ‘Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass on Weight Loss, Comorbidities, and Reflux at 10 Years in Adult Patients With Obesity - The SLEEVEPASS Randomized Clinical Trial’, published in JAMA Network, written on behalf of the SLEEVEPASS trial investigators.
The ten-year observational study evaluated 240 patients in the Sleeve vs Bypass (SLEEVEPASS) multicentre equivalence randomised clinical trial comparing LSG and LRYGB in the treatment of severe obesity in which 240 patients aged 18 to 60 years with median body mass index of 44.6 were randomized to LSG (n=121) or LRYGB (n = 119). The initial trial was conducted from April 2008 to June 2010 in Finland, with last follow-up in January 2021. The primary end point was five-year %EWL), this latest paper analysis focused on ten-year outcomes with special reference to reflux and BE.
Previously reported outcomes at five and seven years, both LSG and LRYGB resulted in good weight loss outcomes, similar remission of type 2 diabetes and dyslipidaemia, and no difference in quality of life (QOL) or morbidity. However, LRYGB was superior for hypertension remission although weight loss between the groups was not clinically significant.
Two patients in the LRYGB group did not have surgery, resulting in a total of 238 patients who underwent operations. There were ten deaths unrelated to intervention (five in each group). Of the 228 available patients, 193 (84.6%) completed the ten-year follow-up on weight loss, remission of comorbidities, QOL, and GERD symptoms, and 176 (77.2%) underwent gastroscopy.
At ten years, the estimated mean %EWL was 43.5% after LSG and 51.9% after LRYGB. The model-based estimate of mean %EWL was 8.4 percentage points higher after LRYGB (based on predefined margins of equivalence (−9 to 9), the two groups were not equivalent for weight loss as the whole confidence interval was not within the predefined margins).
The prevalence of esophagitis was significantly higher after LSG than LRYGB; 31% (28 of 91) vs 7% (6 of 85), respectively (p<0.001). De novo BE was found in four of 91 patients (4%) after LSG and in three of 85 (4%) after LRYGB (p=0.29). Patients in the LSG group had significantly greater PPI intake (58 of 90 [64%] vs 30 of 84 [36%]; p<0.001), higher GERD-HRQL total score (10.5 vs 0.0; p<0.001), and more reflux symptoms vs patients in the LRYGB group at ten years. Patients with esophagitis after LSG had significantly more de novo GERD symptoms compared with the retrospective subjective assessment of the preoperative status and higher GERD-HRQL total scores (15.0 vs 0.0; p=0.03) vs with patients in the LRYGB group presenting with esophagitis.
At baseline, 101 patients (42%) had type 2 diabetes (LSG, 52 of 121 [43%]; LRYGB, 49 of 119 [41%]). At 10 years, remission of type 2 diabetes was seen in 11 of 42 patients (26%) after LSG and in 13 of 39 (33%) after LRYGB (p=0.63). Type 2 diabetes preoperative duration was statistically significantly associated with remission of type 2 diabetes: 0 to two years, 12 of 23 (52%), more than two to ten years, 12 of 48 (25%), and more than 10 years, 0 of 9 (0%) (p=0.01).
At baseline, 84 patients (35%) had dyslipidaemia (LSG, 39 of 121 [32%]; LRYGB, 45 of 119 [38%]). At ten years, remission of dyslipidaemia with normal lipid values and no medication was seen in four of 21 patients (19%) after LSG and in 11 of 31 (35%) after LRYGB, (p=0.23).
At baseline, 170 patients (70.8%) had medication for hypertension (LSG, 83 of 121 [69%]; LRYGB, 87 of 119 [73%]). At ten years, six of 72 patients (8%) after LSG vs 16 of 68 (24%) after LRYGB had discontinued medication, 23 of 72 (32%) vs 16 of 68 (24%) had reduced antihypertensive medications, and 43 of 72 (60%) vs 36 of 68 (53%) had no change in medication, respectively (p=0.04).
At baseline, 65 patients (27.1%) had obstructive sleep apnoea (LSG, 30 of 121 [24.8%]; LRYGB, 35 of 119 [29.4%]). At ten years, five of 31 patients (16%) in the LSG group vs 9 of 29 (31%) in the LRYGB group had discontinued using CPAP, eight of 31 (26%) vs four of 29 (14%) had reduced CPAP settings, and 18 of 31 (58%) vs 16 of 29 (55%) had no change in CPAP settings, respectively (p=0.30).
The overall minor complication rate (Clavien-Dindo I-IIIa) at ten years was 34.7% (42 of 121) for LSG and 24.4% (29 of 119) for LRYGB (p=0.08). The overall major complication rate (ie, reoperation rate, Clavien-Dindo IIIb) was 15.7% (19 of 121) for LSG and 18.5% (22 of 119) for LRYGB (p=0.57). Most of the reoperations in the LSG group (14 of 19) were because of GERD, and most of the reoperations in the LRYGB group (18 of 22) were due to internal herniation.
“The cumulative incidence of BE was markedly lower than in previous trials and similar after both procedures, but endoscopic esophagitis, GERD symptoms, and PPI use were more prevalent after LSG, underlining the importance of preoperative GERD assessment and patient selection” the authors concluded. “There was no statistically significant difference in type 2 diabetes, dyslipidaemia, and obstructive sleep apnoea, but LRYGB resulted in superior remission of hypertension.”
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