Laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy: 5-year outcomes of merged data from two randomized clinical trials (SLEEVEPASS and SM-BOSS).

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) and Roux-en-Y gastric bypass (LRYGB) are both effective surgical procedures to achieve weight reduction in patients with obesity. The trial objective was to merge individual-patient data from two RCTs to compare outcomes after LSG and LRYGB. METHODS: Five-year outcomes of the Finnish SLEEVEPASS and Swiss SM-BOSS RCTs comparing LSG with LRYGB were analysed. Both original trials were designed to evaluate weight loss. Additional patient-level data on type 2 diabetes (T2DM), obstructive sleep apnoea, and complications were retrieved. The primary outcome was percentage excess BMI loss (%EBMIL). Secondary predefined outcomes in both trials included total weight loss, remission of co-morbidities, improvement in quality of life (QoL), and overall morbidity. RESULTS: At baseline, 228 LSG and 229 LRYGB procedures were performed. Five-year follow-up was available for 199 of 228 patients (87.3 per cent) after LSG and 199 of 229 (87.1 per cent) after LRYGB. Model-based mean estimate of %EBMIL was 7.0 (95 per cent c.i. 3.5 to 10.5) percentage points better after LRYGB than after LSG  (62.7 versus 55.5 per cent respectively; P < 0.001). There was no difference in remission of T2DM, obstructive sleep apnoea or QoL improvement; remission for hypertension was better after LRYGB compared with LSG (60.3 versus 44.9 per cent; P = 0.049). The complication rate was higher after LRYGB than LSG (37.2 versus 22.5 per cent; P = 0.001), but there was no difference in mean Comprehensive Complication Index value (30.6 versus 31.0 points; P = 0.859). CONCLUSION: Although LRYGB induced greater weight loss and better amelioration of hypertension than LSG, there was no difference in remission of T2DM, obstructive sleep apnoea, or QoL at 5 years. There were more complications after LRYGB, but the individual burden for patients with complications was similar after both operations.

Obstructive sleep apnea: the effect of bariatric surgery after 12 months. A prospective multicenter trial.

BACKGROUND: Obstructive sleep apnea (OSA) is a highly prevalent sleep disorder, particularly in bariatric patients. It is known to be tightly linked with metabolic abnormalities and cardiovascular morbidity. Obesity is the most noteworthy individual risk factor for OSA. The aim of this study was to investigate the effect of a laparoscopic Roux-en-Y gastric bypass (LRYGB) on OSA one year after surgery. METHODS: In this prospective multicenter study standard overnight cardiorespiratory recording was conducted 12 months after bariatric surgery in 132 patients who had OSA in the baseline recording prior to the operation. The main outcome measures were changes in the prevalence of OSA and apnea-hypopnea index (AHI). In addition, the changes in anthropometric and demographic measurements including weight, body mass index (BMI), and waist and neck circumference were evaluated. A sleep symptom questionnaire was administered at baseline and at 12 months. RESULTS: The prevalence of OSA decreased from 71% at baseline to 44% at 12 months after surgery (p < 0.001). OSA was cured in 45% and cured or improved in 78% of the patients, but moderate or severe OSA still persisted in 20% of the patients after the operation. De novo OSA occurred in eight percent of the patients, and total AHI decreased from 27.8 events/h to 9.9 events/h (p < 0.001). CONCLUSIONS: LRYGB is effective in treating OSA. However, the findings demonstrate that a postoperative cardiorespiratory recording is needed in order to identify the patients with persistent moderate to severe OSA after the operation. CLINICAL TRIAL REGISTRATION: ClinalTrials.gov; No.: NCT01080404; URL: www.clinicaltrials.gov.

Prevalence of Obstructive Sleep Apnoea Among Patients Admitted for Bariatric Surgery. A Prospective Multicentre Trial.

BACKGROUND: Obesity has become one of the greatest public health concerns worldwide and is known to be the most important risk factor for obstructive sleep apnoea (OSA). Prevalence of OSA has increased over the last two decades, but it is estimated that the majority of cases still remain undiagnosed. The aim of this study was to investigate the prevalence of OSA in Finnish bariatric surgery candidates. METHODS: In this prospective multicentre study, standard overnight cardiorespiratory recording was conducted in 197 consecutive patients from three different hospitals. A sleep questionnaire was also administered. Anthropometric and demographic measurements included age, weight, body mass index (BMI) and waist and neck circumference. RESULTS: Altogether, 71 % of the patients were diagnosed with OSA. The prevalence was higher in males (90 %) than in females (60 %) (p < 0.001). In OSA patients' group, the mean neck and waist circumference was larger (p < 0.001) and the body weight higher (p < 0.01) than in non-OSA group. When separating patients by gender, a significant difference remained only concerning neck circumference in female patients. CONCLUSIONS: OSA is very common among bariatric surgery patients, especially in men. Considering this and the increased long-term morbidity and mortality generally related to OSA, a routine screening for OSA seems indicated in bariatric patients, particularly men.

Comparison of short-term outcome of laparoscopic sleeve gastrectomy and gastric bypass in the treatment of morbid obesity: A prospective randomized controlled multicenter SLEEVEPASS study with 6-month follow-up.

BACKGROUND AND AIMS: The long-term efficacy of laparoscopic Roux-en-Y gastric bypass in the treatment of morbid obesity has already been demonstrated. Laparoscopic sleeve gastrectomy has shown promising short-term results, but the long-term efficacy is still unclear. The aim of this prospective randomized multicenter study is to compare the results of Roux-en-Y gastric bypass and sleeve gastrectomy. MATERIAL AND METHODS: A total of 240 morbidly obese patients were randomized to undergo either Roux-en-Y gastric bypass or sleeve gastrectomy. The primary end point of study was weight loss, and the secondary end points were resolution of comorbidities and morbidity. The short-term results at 6 months were analyzed. RESULTS: The mean excess weight loss at 6 months was 49.2% in the sleeve gastrectomy group and 52.9% in the Roux-en-Y gastric bypass group (p = 0.086). Type 2 diabetes was resolved or improved in 84.3% of patients in the sleeve gastrectomy group and 93.3% in the Roux-en-Y gastric bypass group (p = 0.585). The corresponding results for arterial hypertension were 76.8% and 81.9% (p = 0.707) and for hypercholesterolemia 64.1% and 69.0% (p = 0.485). There was no mortality at 6 months. There was one major complication following sleeve gastrectomy and two after Roux-en-Y gastric bypass (p = 0.531). Eight sleeve gastrectomy patients and 11 Roux-en-Y gastric bypass patients had minor complications (p = 0.403). CONCLUSION: The short-term results of sleeve gastrectomy and Roux-en-Y gastric bypass regarding weight loss, resolution of obesity-related comorbidities and complications were not different at 6 months.

Is routine preoperative upper GI endoscopy needed prior to gastric bypass?

BACKGROUND: In Finland, upper GI endoscopy (UGI) prior to bariatric surgery is routine in all but one hospital performing bariatric surgery. However, UGI is an unpleasant investigation for the patient and requires resources. Helicobacter pylori (HP) can be tested from blood and cannot be considered as an indication for UGI. We wanted to identify the most common findings in UGI and see if the findings influenced the decision to operate or if they even canceled the operation. METHODS: We evaluated retrospectively the data of 412 patients undergoing preoperative UGI in Vaasa Central Hospital in the years 2006-2010. RESULTS: UGI was considered normal in 191 (55.8 %) patients. The most common findings were hiatal hernia in 25.4 % (n = 87); gastritis, 13.7 % (n = 47); and esophagitis, 13.2 % (n = 45). Also benign polyps, 6.7 % (n = 23), and ulcers, 2.9 % (n = 10), were detected. One 0.5-cm esophageal leiomyoma was found, but no malignant lesions. Histology was found normal in 185 (54.1 %) patients. HP was found in 12.0 % (n = 41) of patients. CONCLUSIONS: In this study, all the findings were benign and mild. The findings did not influence the operative plan. The most common findings were hiatal hernia and esophagitis which may be considered contraindications for sleeve gastrectomy, but not for gastric bypass. Our results do not support the performance of routine preoperative UGI prior to gastric bypass.

Perioperative morbidity, mortality and early outcome of the first 360 gastric bypass operations performed in a district hospital.

BACKGROUND AND AIMS: We report the results for the first consecutive 360 Roux-en-Y gastric by-pass (RYGB) operations performed in a district hospital in Finland. MATERIAL AND METHODS: Demographic data, perioperative characteristics, and follow-up data were entered prospectively in the hospital's database for bariatric patients. RESULTS: We performed 325 primary laparoscopic Roux-en-Y gastric bypass (LRYGB) operations, one open RYGB, and 34 revisions. Mean BMI before the operations was 47.5 ± 7.8 kg/m2 (31.5-91.0 kg/m2). The percentage of patients with type 2 diabetes mellitus (T2DM) was high; 52.3% (170 patients). The mean operative time decreased from 110 minutes during the first 108 operations to 82 minutes for the second 108 operations, and to 74 minutes for the last 109 operations (P < 0.001). Postoperative hospital stay was significantly reduced (P < 0.001) for the last 109 patients compared to the first and second group of patients. Overall morbidity averaged 19.1% (62/325). Severe complications were detected in 15 patients (4.6%). There was a tendency to more serious complications in the first group of patients. There was one death (mortality 0.3%). With a follow-up rate of 97% at 3 months T2DM had resolved in 48.2%, and had resolved or improved in a minimum of 92.9% of the diabetic patients. Weight loss (WL) and excess weight loss (EWL) averaged 20% and 46% respectively. CONCLUSIONS: Operative time and postoperative hospital stay decrease significantly with increasing experience. The first one hundred patients may be at higher risk for complications. LRYGB operations may have an important impact on the resolution of T2DM in the operated population.