Early Results of Swiss Multicentre Bypass or Sleeve Study
Early Results of Swiss Multicentre Bypass or Sleeve Study
Objective: Laparoscopic sleeve gastrectomy (LSG) has been proposed as an effective alternative to the current standard procedure, laparoscopic Roux-en-Y gastric bypass (LRYGB). Prospective data comparing both procedures are rare. Therefore, we performed a randomized clinical trial assessing the effectiveness and safety of these 2 operative techniques.
Methods: Two hundred seventeen patients were randomized at 4 bariatric centers in Switzerland. One hundred seven patients underwent LSG using a 35-F bougie with suturing of the stapler line, and 110 patients underwent LRYGB with a 150-cm antecolic alimentary and a 50-cm biliopancreatic limb. The mean body mass index of all patients was 44 ± 11.1 kg/m, the mean age was 43 ± 5.3 years, and 72% were female.
Results: The 2 groups were similar in terms of body mass index, age, sex, comorbidities, and eating behavior. The mean operative time was less for LSG than for LRYGB (87 ± 52.3 minutes vs 108 ± 42.3 minutes; P = 0.003). The conversion rate was 0.9% in both groups. Complications (<30 days) occurred more often in LRYGB than in LSG (17.2% vs 8.4%; P = 0.067). However, the difference in severe complications did not reach statistical significance (4.5% for LRYGB vs 1% for LSG; P = 0.21). Excessive body mass index loss 1 year after the operation was similar between the 2 groups (72.3% ± 22% for LSG and 76.6% ± 21% for LRYGB; P = 0.2). Except for gastroesophageal reflux disease, which showed a higher resolution rate after LRYGB, the comorbidities and quality of life were significantly improved after both procedures.
Conclusions: LSG was associated with shorter operation time and a trend toward fewer complications than with LRYGB. Both procedures were almost equally efficient regarding weight loss, improvement of comorbidities, and quality of life 1 year after surgery. Long-term follow-up data are needed to confirm these facts.
Bariatric surgery has been recognized as an effective and safe treatment option for morbid obesity and its related comorbidities. For the last 2 decades, Roux-en-Y gastric bypass has been considered as the treatment of choice for obesity World Health Organization grade III, with an acceptable complication rate, long-lasting weight control, and efficient reduction of comorbidities, especially type 2 diabetes (T2DM). The dramatically increasing prevalence of obesity has led to the development of alternative treatment strategies including new operative techniques, such as the laparoscopic sleeve gastrectomy (LSG), which was first described in 2003 by Regan et al in a staged concept. LSG is suggested to be a technically less demanding operation than laparoscopic Roux-en-Y gastric bypass (LRYGB), which offers some potential benefits over the LRYGB. Because the intestinal passage is still intact after LSG endoscopy of the remaining stomach and access to the duodenum is still possible, the risk of internal hernias is absent. In case of insufficient weight loss, LRYGB or biliopancreatic diversion with duodenal switch can be performed as a second-stage procedure. However, there has been some concern regarding onset or worsening of reflux and leakages after LSG, with the latter (although rare) being rather demanding to treat. LSG has gained popularity throughout the world, but there is still a lot of skepticism among bariatric surgeons regarding achievable long-term results in comparison with the established results of LRYGB. As a consequence, many studies in the past few years have been published assessing the midterm efficacy and safety of LSG. The excessive weight loss ranged from 53% to 69%, and the incidence of staple line leaks and bleeding ranged from 1% to 3%. In 2012, the American Society for Metabolic and Bariatric Surgery published a revised position statement, which proposed that LSG is a valid alternative operation technique to LRYGB. However, currently, the evidence for the superiority of either surgical technique is still weak. Only 3 (2 from the same institution) randomized clinical trials comparing LSG and LRYGB with small patient numbers (16–30 per group) and limited follow-up (12–35 months) have been published so far. Although bariatric operations are currently among the most frequently performed operative procedures in the United States and Europe, a potential outcome difference between LSG and LRYGB would therefore have a substantial impact on the health care systems worldwide. Therefore, we decided to conduct a large multicentric randomized clinical trial assessing the efficacy and safety of LSG and LRYGB to answer this important question.
Abstract and Introduction
Abstract
Objective: Laparoscopic sleeve gastrectomy (LSG) has been proposed as an effective alternative to the current standard procedure, laparoscopic Roux-en-Y gastric bypass (LRYGB). Prospective data comparing both procedures are rare. Therefore, we performed a randomized clinical trial assessing the effectiveness and safety of these 2 operative techniques.
Methods: Two hundred seventeen patients were randomized at 4 bariatric centers in Switzerland. One hundred seven patients underwent LSG using a 35-F bougie with suturing of the stapler line, and 110 patients underwent LRYGB with a 150-cm antecolic alimentary and a 50-cm biliopancreatic limb. The mean body mass index of all patients was 44 ± 11.1 kg/m, the mean age was 43 ± 5.3 years, and 72% were female.
Results: The 2 groups were similar in terms of body mass index, age, sex, comorbidities, and eating behavior. The mean operative time was less for LSG than for LRYGB (87 ± 52.3 minutes vs 108 ± 42.3 minutes; P = 0.003). The conversion rate was 0.9% in both groups. Complications (<30 days) occurred more often in LRYGB than in LSG (17.2% vs 8.4%; P = 0.067). However, the difference in severe complications did not reach statistical significance (4.5% for LRYGB vs 1% for LSG; P = 0.21). Excessive body mass index loss 1 year after the operation was similar between the 2 groups (72.3% ± 22% for LSG and 76.6% ± 21% for LRYGB; P = 0.2). Except for gastroesophageal reflux disease, which showed a higher resolution rate after LRYGB, the comorbidities and quality of life were significantly improved after both procedures.
Conclusions: LSG was associated with shorter operation time and a trend toward fewer complications than with LRYGB. Both procedures were almost equally efficient regarding weight loss, improvement of comorbidities, and quality of life 1 year after surgery. Long-term follow-up data are needed to confirm these facts.
Introduction
Bariatric surgery has been recognized as an effective and safe treatment option for morbid obesity and its related comorbidities. For the last 2 decades, Roux-en-Y gastric bypass has been considered as the treatment of choice for obesity World Health Organization grade III, with an acceptable complication rate, long-lasting weight control, and efficient reduction of comorbidities, especially type 2 diabetes (T2DM). The dramatically increasing prevalence of obesity has led to the development of alternative treatment strategies including new operative techniques, such as the laparoscopic sleeve gastrectomy (LSG), which was first described in 2003 by Regan et al in a staged concept. LSG is suggested to be a technically less demanding operation than laparoscopic Roux-en-Y gastric bypass (LRYGB), which offers some potential benefits over the LRYGB. Because the intestinal passage is still intact after LSG endoscopy of the remaining stomach and access to the duodenum is still possible, the risk of internal hernias is absent. In case of insufficient weight loss, LRYGB or biliopancreatic diversion with duodenal switch can be performed as a second-stage procedure. However, there has been some concern regarding onset or worsening of reflux and leakages after LSG, with the latter (although rare) being rather demanding to treat. LSG has gained popularity throughout the world, but there is still a lot of skepticism among bariatric surgeons regarding achievable long-term results in comparison with the established results of LRYGB. As a consequence, many studies in the past few years have been published assessing the midterm efficacy and safety of LSG. The excessive weight loss ranged from 53% to 69%, and the incidence of staple line leaks and bleeding ranged from 1% to 3%. In 2012, the American Society for Metabolic and Bariatric Surgery published a revised position statement, which proposed that LSG is a valid alternative operation technique to LRYGB. However, currently, the evidence for the superiority of either surgical technique is still weak. Only 3 (2 from the same institution) randomized clinical trials comparing LSG and LRYGB with small patient numbers (16–30 per group) and limited follow-up (12–35 months) have been published so far. Although bariatric operations are currently among the most frequently performed operative procedures in the United States and Europe, a potential outcome difference between LSG and LRYGB would therefore have a substantial impact on the health care systems worldwide. Therefore, we decided to conduct a large multicentric randomized clinical trial assessing the efficacy and safety of LSG and LRYGB to answer this important question.
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