METHODS: In this open-label, phase 3, multicentre randomised trial, patients aged 21-80 years with cT3 or cT4 gastric cancer undergoing curative resection were enrolled at 22 centres from South Korea, China, Japan, Malaysia, Hong Kong, and Singapore. Patients were randomly assigned to receive surgery and EIPL (EIPL group) or surgery alone (standard surgery group) via a web-based programme in random permuted blocks in varying block sizes of four and six, assuming equal allocation between treatment groups. Randomisation was stratified according to study site and the sequence was generated using a computer program and concealed until the interventions were assigned. After surgery in the EIPL group, peritoneal lavage was done with 1 L of warm (42°C) normal 0·9% saline followed by complete aspiration; this procedure was repeated ten times. The primary endpoint was overall survival. All analyses were done assuming intention to treat. This trial is registered with ClinicalTrials.gov, NCT02140034.
FINDINGS: Between Sept 16, 2012, and Aug 3, 2018, 800 patients were randomly assigned to the EIPL group (n=398) or the standard surgery group (n=402). Two patients in the EIPL group and one in the standard surgery group withdrew from the trial immediately after randomisation and were excluded from the intention-to-treat analysis. At the third interim analysis on Aug 28, 2019, the predictive probability of overall survival being significantly higher in the EIPL group was less than 0·5%; therefore, the trial was terminated on the basis of futility. With a median follow-up of 2·4 years (IQR 1·5-3·0), the two groups were similar in terms of overall survival (hazard ratio 1·09 [95% CI 0·78-1·52; p=0·62). 3-year overall survival was 77·0% (95% CI 71·4-81·6) for the EIPL group and 76·7% (71·0-81·5) for the standard surgery group. 60 adverse events were reported in the EIPL group and 41 were reported in the standard surgery group. The most common adverse events included anastomotic leak (ten [3%] of 346 patients in the EIPL group vs six [2%] of 362 patients in the standard surgery group), bleeding (six [2%] vs six [2%]), intra-abdominal abscess (four [1%] vs five [1%]), superficial wound infection (seven [2%] vs one [<1%]), and abnormal liver function (six [2%] vs one [<1%]). Ten of the reported adverse events (eight in the EIPL group and two in the standard surgery group) resulted in death.
INTERPRETATION: EIPL and surgery did not have a survival benefit compared with surgery alone and is not recommended for patients undergoing curative gastrectomy for gastric cancer.
FUNDING: National Medical Research Council, Singapore.
Presentation of case: We describe the successful management of MLL of the left medial thigh in a 35-year-old man weighing 220 kgs (BMI 80.8 kgs/m2). He underwent a concurrent laparoscopic sleeve gastrectomy with surgical resection of the MLL. He recovered well and during our last follow up six months after the operation, he is ambulating well and weighs 148 kgs (BMI 54.4 kgs/m2).
Discussion: MLL is a form of secondary lymphedema resulting in disruption or compression of normal lymphatic drainage due to fat accumulation in obese patients. Patients usually delay treatment for even up to a decade, when it becomes sufficiently large enough to restrict mobility and daily activities, or when it becomes infected. MLL is primarily a clinical diagnosis. A detailed history regarding its slow growth spanning over the years makes malignancy less likely. However, if left untreated, MLL may progress to angiosarcoma. Imaging studies such as computed tomography (CT) and a Magnetic Resonance Imaging (MRI) are usually performed to rule out malignancy or vascular malformations. A tissue biopsy is not recommended unless there are suspicious pigmented lesions.
Conclusion: MLL remains to be underdiagnosed. Due to the obesity epidemic, clinicians must be aware of this once rare disease. The role of concurrent bariatric surgery with surgical resection of MLL warrants further studies.
RESEARCH DESIGN AND METHODS: Outcomes of 736 patients with T2DM who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) at an academic center (2004-2012) and had ≥5 years' glycemic follow-up were assessed. Of 736 patients, 425 (58%) experienced diabetes remission (HbA1c <6.5% [48 mmol/mol] with patients off medications) in the 1st year after surgery. These 425 patients were followed for a median of 8 years (range 5-14) to characterize late relapse of diabetes.
RESULTS: In 136 (32%) patients who experienced late relapse, a statistically significant improvement in glycemic control, number of diabetes medications including insulin use, blood pressure, and lipid profile was still observed at long-term. Independent baseline predictors of late relapse were preoperative number of diabetes medications, duration of T2DM before surgery, and SG versus RYGB. Furthermore, patients who relapsed lost less weight during the 1st year after surgery and regained more weight afterward. Prediction models were constructed and externally validated.
CONCLUSIONS: While late relapse of T2DM is a real phenomenon (one-third of our cohort), it should not be considered a failure, as the trajectory of the disease and its related cardiometabolic risk factors is changed favorably after bariatric surgery. Earlier surgical intervention, RYGB (compared with SG) and more weight loss (less late weight regain) are associated with less diabetes relapse in the long-term.
METHODS: We studied 101 patients with pre-operative diabetes and albuminuria [defined as urine albumin:creatinine ratio (uACR) > 30 mg/g] who underwent bariatric surgery at an academic center from 2005 to 2014.
RESULTS: Fifty-seven patients (56%) were female with a mean age of 53 (± 11) years. The mean pre-operative BMI and glycated hemoglobin (HbA1c) were 43.1 (± 7.6) kg/m2 and 8.4 (± 1.8)%, respectively. The median pre-operative uACR was 80.0 (45.0-231.0) mg/g. Bariatric procedures included Roux-en-Y gastric bypass (n = 75, 74%) and sleeve gastrectomy (n = 26, 26%). The mean follow-up period was 61 (± 29) months. At last follow-up, the mean BMI was 33.8 (± 8.3) kg/m2. The overall glycemic control improved after bariatric surgery. At last follow-up, 73% had good glycemic control (HbA1c
OBJECTIVES: The aim of this study was to describe trends in warfarin dosing after Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG).
SETTING: Single academic center.
METHODS: All patients chronically on warfarin anticoagulation before RYGB or SG were retrospectively identified. Indications for anticoagulation, history of bleeding or thrombotic events, perioperative complications, and warfarin dosing were collected.
RESULTS: Fifty-three patients (RYGB n = 31, SG n = 22) on chronic warfarin therapy were identified (56.6% female, mean 54.4 ± 11.7 yr of age). Of this cohort, 34.0% had prior venous thromboembolic events, 43.4% had atrial fibrillation, and 5.7% had mechanical cardiac valves. Preoperatively, the average daily dose of warfarin was similar in the RYGB group (8.3 ± 4.1 mg) and SG group (6.9 ± 2.8 mg). One month after surgery, mean daily dose of warfarin was reduced 24.1% in the RYGB group (P
METHODS: All the patients with end-stage heart failure (ESHF) and implanted LVAD who underwent LSG from2013 to January 2017 were studied.
RESULTS: Seven patients with end stage heart failure (ESHF) and implanted LVAD were included. The median age and median preoperative BMI were 39 years (range: 26-62) and 43.6 kg/m2 (range 36.7-56.7), respectively. The median interval between LVAD implantation and LSG was 38 months (range 15-48). The median length of hospital stay was 9 days (rang: 6-23) out of which 4 patients had planned postoperative ICU admission. Thirty-day complications were noted in 5 patients (3 major and 2 minor) without any perioperative mortality. The median duration of follow-up was 24 months (range 2-30). At the last available follow-up, the median BMI, %EWL, and %TWL were 37 kg/m2, 47%, and 16%, respectively. The median LVEF before LSG and at the last follow-up point (before heart transplant) was 19% (range 15-20) and 22% (range, 16-35), respectively. In addition, the median NYHA class improved from 3 to 2 after LSG. Three patients underwent successful heart transplantations.
CONCLUSION: Patients with morbid obesity, ESHF, and implanted LVAD constitute a high-risk cohort. Our results with 7 patients and result from other studies (19 patients) suggested that bariatric surgery may be a reasonable option for LVAD patients with severe obesity. Bariatric surgery appears to provide significant weight loss in these patients and may improve candidacy for heart transplantation.
MATERIAL AND METHODS: Individuals undergoing primary sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) from February 2008 to December 2015 were included. Impaired mobility (WC) was defined as using a wheelchair or motorized scooter for at least part of a typical day. The WC group was propensity score matched to ambulatory patients (1:5 ratio). Comparisons were made for 30-day morbidity and mortality and 1-year improvement in weight-related comorbidities.
RESULTS: There were 93 patients in the WC group matched to 465 ambulatory controls. The median operative time (180 vs 159 min, p = 0.003) and postoperative length of stay (4 vs 3 days, p ≤ 0.001) was higher in the WC group. There were no differences in readmission or all-cause morbidity within 30 days. The median percent excess weight loss (%EWL) at 1 year was similar (WC group, 65% available, 53% EWL vs AMB group, 73% available, 54% EWL); however, patients with impaired mobility were less likely to experience improvement in diabetes (76 vs 90%, p = 0.046), hypertension (63 vs 82%, p
BACKGROUND: Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) account for >95% of bariatric procedures in United States in patients with T2DM. To date, there is no validated model to guide procedure selection based on long-term glucose control in patients with T2DM.
METHODS: A total of 659 patients with T2DM who underwent RYGB and SG at an academic center in the United States and had a minimum 5-year follow-up (2005-2011) were analyzed to generate the model. The validation dataset consisted of 241 patients from an academic center in Spain where similar criteria were applied.
RESULTS: At median postoperative follow-up of 7 years (range 5-12), diabetes remission (HbA1C <6.5% off medications) was observed in 49% after RYGB and 28% after SG (P < 0.001). Four independent predictors of long-term remission including preoperative duration of T2DM (P < 0.0001), preoperative number of diabetes medications (P < 0.0001), insulin use (P = 0.002), and glycemic control (HbA1C < 7%) (P = 0.002) were used to develop the Individualized Metabolic Surgery (IMS) score using a nomogram. Patients were then categorized into 3 stages of diabetes severity. In mild T2DM (IMS score ≤25), both procedures significantly improved T2DM. In severe T2DM (IMS score >95), when clinical features suggest limited functional β-cell reserve, both procedures had similarly low efficacy for diabetes remission. There was an intermediate group, however, in which RYGB was significantly more effective than SG, likely related to its more pronounced neurohormonal effects. Findings were externally validated and procedure recommendations for each severity stage were provided.
CONCLUSIONS: This is the largest reported cohort (n = 900) with long-term postoperative glycemic follow-up, which, for the first time, categorizes T2DM into 3 validated severity stages for evidence-based procedure selection.
METHODS: A systematic review of randomized controlled trials (RCTs) was undertaken using the PRISMA guidelines to investigate the postoperative impact on diabetes resolution following LVSG versus LRYGB.
RESULTS: Seven RCTs involving a total of 732 patients (LVSG n = 365, LRYGB n = 367) met inclusion criteria. Significant diabetes resolution or improvement was reported with both procedures across all time points. Similarly, measures of glycemic control (HbA1C and fasting blood glucose levels) improved with both procedures, with earlier improvements noted in LRYGB that stabilized and did not differ from LVSG at 12 months postoperatively. Early improvements in measures of insulin resistance in both procedures were also noted in the studies that investigated this.
CONCLUSIONS: This systematic review of RCTs suggests that both LVSG and LRYGB are effective in resolving or improving preoperative type 2 diabetes in obese patients during the reported 3- to 5-year follow-up periods. However, further studies are required before longer-term outcomes can be elucidated. Areas identified that need to be addressed for future studies on this topic include longer follow-up periods, standardized definitions and time point for reporting, and financial analysis of outcomes obtained between surgical procedures to better inform procedure selection.
OBJECTIVES: The aim of this study was to look at our intermediate outcomes after LDJB-SG.
SETTING: An academic medical center.
METHODS: A prospective analysis of T2D patients who underwent LDJB-SG between October 2011 and October 2014 was performed. Data collected included baseline demographic, body mass index, fasting blood glucose, glycosylated hemoglobin, C-peptide, resolution of co-morbidities, and postoperative complications.
RESULTS: A total of 163 patients with minimum of follow-up >1 year were enrolled in this study (57 men and 106 women). The mean age and body mass index were 47.7 (±10.7) years and a 30.2 (±5.1) kg/m2, respectively. There were 119 patients on oral hypoglycemic agents only, 29 patients were on oral hypoglycemic agents and insulin, 3 patients were on insulin only, and the other 12 patients were not on diabetic medication. Mean operation time and length of hospital stay were 144.7 (± 45.1) minutes and 2.4 (± 1.0) days, respectively. Seven patients (3.6%) needed reoperation due to bleeding (n = 1), anastomotic leak (n = 2), sleeve strictures (n = 2), and incisional hernia (n = 2). At 2 years of follow-up, there were 56 patients. None of the patients were on insulin and only 20% of patients were on oral hypoglycemic agents. Mean body mass index significantly dropped to 22.9 (±5.6) kg/m2 at 2 years. The mean preoperative fasting blood glucose, glycosylated hemoglobin, and C-peptide levels were 174.7 mg/dL (± 61.0), 8.8% (±1.8), and 2.6 (±1.7) ng/mL, respectively. The mean fasting blood glucose, glycosylated hemoglobin, and C-peptide at 2 years were 112.5 (±60.7) mg/dL, 6.4% (±2.0), and 1.5 (±0.6) ng/mL, respectively. No patient needed revisional surgery because of dumping syndrome, marginal ulcer, or gastroesophageal reflux disease at the last follow up period.
CONCLUSION: At 2 years, LDJB-SG is a relatively safe and effective metabolic surgery with significant weight loss and resolution of co-morbidities.
METHODS: A retrospective review of CAT patients undergoing bariatric surgery at an academic center from 2008 to 2015 was studied.
RESULTS: A total of 153 patients on CAT underwent surgery [Roux-en-Y gastric bypass (n = 79), sleeve gastrectomy (n = 63), and adjustable gastric banding (n = 11)] during the study period: 85 patients (55%) were females; median age was 56 years (interquartile range [IQR] 49-64), and median BMI was 49 kg/m2 (IQR 43-56). The most common indications for CAT were venous thromboembolism (n = 87) and atrial fibrillation (n = 83). Median duration of procedure and estimated intraoperative blood loss was 150 min (IQR 118-177) and 50 ml (IQR 25-75), respectively. Thirty-day postoperative complications were reported in 33 patients (21.6%) including postoperative bleeding (n = 19), anastomotic leak (n = 3), and pulmonary embolism (n = 1). Nineteen patients (12%) with early postoperative bleeding were further categorized to intra-abdominal (n = 10), intraluminal (n = 6), and at the port site or abdominal wall (n = 3). All-cause readmissions within 30 days of surgery occurred in 19 patients (12%). There was no 30-day mortality.
CONCLUSION: In our experience, patients who require chronic anticoagulation medication are higher than average risk for postoperative complications and all-cause readmission rates. Careful surgical technique and close attention to postoperative anticoagulation protocols are essential to decrease perioperative risk in this high-risk cohort.
METHODS: A 37-item questionnaire-based survey was conducted to capture the perioperative practices of the global community of bariatric surgeons. Data were analyzed using descriptive statistics.
RESULTS: Response of 863 bariatric surgeons from 67 countries with a cumulative experience of 520,230 SGs were recorded. A total of 689 (80%) and 764 (89%) surgeons listed 13 absolute and relative contraindications, respectively. 65% (n = 559) surgeons perform routine preoperative endoscopy and 97% (n = 835) routinely use intraoperative orogastric tube for sizing the resection. A wide variation is observed in the diameter of the tube used. 73% (n = 627) surgeons start dividing the stomach at a distance of 3-5 cm from the pylorus, and 54% (n = 467) routinely use staple line reinforcement. Majority (65%, n = 565) of surgeons perform routine intraoperative leak test at the end of the procedure, while 25% (n = 218) surgeons perform a routine contrast study in the early postoperative period. Lifelong multivitamin/mineral, iron, vitamin D, calcium, and vitamin B12 supplementation is advocated by 66%, 29%, 40%, 38% and 44% surgeons, respectively.
CONCLUSION: There is a considerable variation in the perioperative practices concerning SG. Data can help in identifying areas for future consensus building and more focussed studies.
METHODS: Patients at a single academic institution who underwent bariatric surgery and developed neurologic complications secondary to low levels of vitamins B1, B2, B6, and B12 between the years 2004 and 2015 were studied.
RESULTS: In total, 47 (0.7%) bariatric surgical patients (Roux-en-Y gastric bypass n = 36, sleeve gastrectomy n = 9, and duodenal switch n = 2) developed neurologic manifestations secondary to vitamin B deficiencies. Eleven (23%) patients developed postoperative anatomical complications contributed to poor oral intake. Median duration to onset of neurologic manifestation following surgery was 12 months (IQR, 5-32). Vitamin deficiencies reported in the cohort included B1 (n = 30), B2 (n = 1), B6 (n = 12), and B12 (n = 12) deficiency. The most common manifestations were paresthesia (n = 31), muscle weakness (n = 15), abnormal gait (n = 11), and polyneuropathy (n = 7). Four patients were diagnosed with Wernicke-Korsakoff syndrome (WKS) which was developed after gastric bypass (n = 3) and sleeve gastrectomy (n = 1). Seven patients required readmission for management of severe vitamin B deficiencies. Overall, resolution of neurologic symptoms with nutritional interventions and pharmacotherapy was noted in 40 patients (85%). The WKS was not reversible, and all four patients had residual mild ataxia and nystagmus at the last follow-up time.
CONCLUSIONS: Nutritional neurologic disorders secondary to vitamin B deficiency are relatively uncommon after bariatric surgery. While neurologic disorders are reversible in most patients (85%) with vitamin replacements, persistent residual neurologic symptoms are common in patients with WKS.
METHODS: Data of seven patients undergoing laparoscopic transgastric resection were identified and retrospectively reviewed with regard to procedural steps and patient outcomes.
RESULTS: Seven patients (4 men; mean age 64.1 ± 14.6 years) with gastric GISTs underwent laparoscopic transgastric resection from January 2010 to May 2015. Three of the seven GISTs were located near the gastroesophageal junction and the rest were found in the posterior wall of the stomach. All seven patients underwent successful laparoscopic resection without any conversions. There were no mortalities and no significant postoperative complications. Intraoperative endoscopy was performed for all patients. The mean operative time was 164.0 ± 59.1 minutes. Regular diet was resumed within 3 days on average and mean postoperative stay was 3.6 ± 1.3 days. All patients achieved complete R0 resection with a mean tumor size of 5.5 ± 1.1 cm. At a mean follow-up of 48.0 ± 13.4 months, all patients were recurrence free.
CONCLUSIONS: GISTs of the posterior wall and in close proximity to the gastroesophageal junction can be safely resected laparoscopically using such an approach. Standard technique is required to achieve good oncological outcomes.
METHODS: RCTs comparing the early complication rates following LVSG and LRYGB between 2000 and 2015 were selected from PubMed, Medline, Embase, Science Citation Index, Current Contents, and the Cochrane database. The outcome variables analyzed included 30-day mortality, major and minor complications and interventions required for their management, length of hospital stay, readmission rates, operating time, and conversions from laparoscopic to open procedures.
RESULTS: Six RCTs involving a total of 695 patients (LVSG n = 347, LRYGB n = 348) reported on early major complications. A statistically significant reduction in relative odds of early major complications favoring the LVSG procedure was noted (p = 0.05). Five RCTs representing 633 patients (LVSG n = 317, LRYGB n = 316) reported early minor complications. A non-statically significant reduction in relative odds of 29 % favoring the LVSG procedure was observed for early minor complications (p = 0.4). However, other outcomes directly related to complications which included reoperation rates, readmission rate, and 30-day mortality rate showed comparable effect size for both surgical procedures.
CONCLUSIONS: This meta-analysis and systematic review of RCTs suggests that fewer early major and minor complications are associated with LVSG compared with LRYGB procedure. However, this does not translate into higher readmission rate, reoperation rate, or 30-day mortality for either procedure.