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.
MATERIALS AND METHODS: Searches of electronic databases (PubMed, Embase, CINAHL, Cochrane) were undertaken for randomized controlled trials describing weight loss outcomes in adults at 5 years postoperatively. Where sufficient data was available to undertake meta-analysis, the Hartung-Knapp-Sidik-Jonkman estimation method for random effects model was utilized. The review was registered with PROSPERO and reported following in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
RESULTS: Five studies met the inclusion criteria totaling 1028 patients (LVSG=520, LRYGB=508). Moderate but comparable levels of bias were observed within studies. Statistically significant body mass index loss ranged from -11.37 kg/m (range: -6.3 to -15.7 kg/m) in the LVSG group and -12.6 kg/m (range: -9.5 to -15.4 kg/m) for LRYGB at 5 years (P<0.001). Systematic review suggested that LRYGB produced a greater weight loss expressed as percent excess weight and percent excess body mass index loss than LVSG: this was not corroborated in the meta-analysis.
CONCLUSIONS: Five year weight loss outcomes suggest both LRYGB and LVSG are effective in achieving significant weight loss at 5 years postoperatively, however, differences in reporting parameters limit the ability to reliably compare the outcomes using statistical methods. Furthermore, results may be impacted by large dropout rates and per protocol analysis of the 2 largest included studies. Further long-term studies are required to contradict or validate the results of this meta-analysis.
MATERIAL AND METHODS: RCTs comparing the weight loss outcomes following LVSG and LRYGB in adult population between January 2000 and November 2015 were selected from PubMed, Medline, Embase, Science Citation Index, Current Contents, and the Cochrane database. The review was prepared in accordance with Preferred Reporting of Systematic Reviews and Meta-Analyses (PRISMA).
RESULTS: Nine unique RCTs described over 10 publications involving a total of 865 patients (LVSG, n=437; LRYGB, n=428) were analyzed. Postoperative follow-up ranged from 3 months to 5 years. Twelve-month excess weight loss (EWL) for LVSG ranged from 69.7% to 83%, and for LRYGB, ranged from 60.5% to 86.4%. A number of studies reported slow weight gain between the second and third years of postoperative follow-up ranging from 1.4% to 4.2%EWL. This trend was seen to continue to 5 years postoperatively (8% to 10%EWL) for both procedures.
CONCLUSIONS: In conclusion, LRYGB and LVSG are comparable with regards to the weight loss outcomes in the short term, with LRYGB achieving slightly greater weight loss. Slow weight recidivism is observed after the first postoperative year following both procedures. Long-term reporting of outcomes obtained from well-designed studies using intention-to-treat analyses are identified as a major gap in the literature at present.
METHODS: Electronic databases (Pubmed, EMBASE, CINAHL) were searched for RCTs conducted in adults (>18y) that compared the 5-year- outcomes of LVSG to LRYGB and described comorbidity outcomes were included. Where data allowed, effect sizes were calculated using the Hartung-Knapp-Sidik-Jonkman estimation method for random effects model. Presence of bias was assessed with Cochrane Risk of Bias 2.0 and funnel plots, and certainty of evidence evaluated by GRADE. The study prospectively registered with PROSPERO (CRD42018112054).
RESULTS: Three RCTs (LVSG=254, LRYGB=255) met inclusion criteria and reported on chronic disease outcomes. Improvement and/or resolution of hypertension favoured LRYGB (odds ratio 0.49, 95% CI 0.29, 0.84; P =0.03). Trends favoring LRYGB were seen for type 2 diabetes and dysplidemia, and LVSG for sleep apnea and back/joint conditions ( P >0.05). The certainty of evidence associated with each assessed outcome ranged from low to very low, in the setting of 'some' to 'high' bias assessed as being present.
CONCLUSION: Both LRYGB and LVSG are effective in providing long-term improvements in commonly experienced obesity-related comorbidities; however, the limited certainty of the evidence does not allow for strong clinical conclusions to be made at this time regarding benefit of one procedure over the other.
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.
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 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.
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: 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.
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.