-
1.
Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for obesity (YOMEGA): a multicentre, randomised, open-label, non-inferiority trial.
Robert, M, Espalieu, P, Pelascini, E, Caiazzo, R, Sterkers, A, Khamphommala, L, Poghosyan, T, Chevallier, JM, Malherbe, V, Chouillard, E, et al
Lancet (London, England). 2019;(10178):1299-1309
Abstract
BACKGROUND One anastomosis gastric bypass (OAGB) is increasingly used in the treatment of morbid obesity. However, the efficacy and safety outcomes of this procedure remain debated. We report the results of a randomised trial (YOMEGA) comparing the outcomes of OAGB versus standard Roux-en-Y gastric bypass (RYGB). METHODS This prospective, multicentre, randomised non-inferiority trial, was held in nine obesity centres in France. Patients were eligible for inclusion if their body-mass index (BMI) was 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, or arthritis), and were aged 18-65 years. Key exclusion criteria were a history of oesophagitis, Barrett's oesophagus, severe gastro-oesophageal reflux disease resistant to proton-pump inhibitors, and previous bariatric surgery. Participants were randomly assigned (1:1) to OAGB or RYGB, stratified by centre with blocks of variable size; the study was open-label, with no masking required. RYGB consisted of a 150 cm alimentary limb and a 50 cm biliary limb and OAGB of a single gastrojejunal anastomosis with a 200 cm biliopancreatic limb. The primary endpoint was percentage excess BMI loss at 2 years. The primary endpoint was assessed in the per-protocol population and safety was assessed in all randomised participants. This study is registered with ClinicalTrials.gov, number NCT02139813, and is now completed. FINDINGS From May 13, 2014, to March 2, 2016, of 261 patients screened for eligibility, 253 (97%) were randomly assigned to OAGB (n=129) or RYGB (n=124). Five patients did not undergo their assigned surgery, and after undergoing their surgery 14 were excluded from the per-protocol analysis (seven due to pregnancy, two deaths, one withdrawal, and four revisions from OAGB to RYGB) In the per-protocol population (n=117 OAGB, n=117 RYGB), mean age was 43·5 years (SD 10·8), mean BMI was 43·9 kg/m2 (SD 5·6), 176 (75%) of 234 participants were female, and 58 (27%) of 211 with available data had type 2 diabetes. After 2 years, mean percentage excess BMI loss was -87·9% (SD 23·6) in the OAGB group and -85·8% (SD 23·1) in the RYGB group, confirming non-inferiority of OAGB (mean difference -3·3%, 95% CI -9·1 to 2·6). 66 serious adverse events associated with surgery were reported (24 in the RYGB group vs 42 in the OAGB group; p=0·042), of which nine (21·4%) in the OAGB group were nutritional complications versus none in the RYGB group (p=0·0034). INTERPRETATION OAGB is not inferior to RYGB regarding weight loss and metabolic improvement at 2 years. Higher incidences of diarrhoea, steatorrhoea, and nutritional adverse events were observed with a 200 cm biliopancreatic limb OAGB, suggesting a malabsorptive effect. FUNDING French Ministry of Health.
-
2.
Effectiveness of different recruitment strategies in an RCT of a surgical device: experience from the Endobarrier trial.
Ruban, A, Prechtl, CG, Glaysher, MA, Chhina, N, Al-Najim, W, Miras, AD, Smith, C, P Goldstone, A, Patel, M, Moore, M, et al
BMJ open. 2019;(11):e032439
Abstract
Recruiting participants into clinical trials is notoriously difficult and poses the greatest challenge when planning any investigative study. Poor recruitment may not only have financial ramifications owing to increased time and resources being spent but could adversely influence the clinical impact of a study if it becomes underpowered. Herein, we present our own experience of recruiting into a nationally funded, multicentre, randomised controlled trial (RCT) of the Endobarrier versus standard medical therapy in obese patients with type 2diabetes. Despite these both being highly prevalent conditions, there were considerable barriers to the effectiveness of different recruitment strategies across each study site. Although recruitment from primary care proved extremely successful at one study site, this largely failed at another site prompting the implementation of multimodal recruitment strategies including a successful media campaign to ensure sufficient participants were enrolled and the study was adequately powered. From this experience, we propose where appropriate the early engagement and investment in media campaigns to enhance recruitment into clinical trials. Trial Registration: ISRCTN30845205.
-
3.
Aspiration therapy for the treatment of obesity: 4-year results of a multicenter randomized controlled trial.
Thompson, CC, Abu Dayyeh, BK, Kushnir, V, Kushner, RF, Jirapinyo, P, Schorr, AB, Aronne, LJ, Amaro, A, Jaffe, DL, Schulman, AR, et al
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2019;(8):1348-1354
Abstract
BACKGROUND The AspireAssist is the first Food and Drug Administration-approved endoluminal device indicated for treatment of class II and III obesity. OBJECTIVES We earlier reported 1-year results of the PATHWAY study. Here, we report 4-year outcomes. SETTING United States-based, 10-center, randomized controlled trial involving 171 participants with the treatment arm receiving Aspiration Therapy (AT) plus Lifestyle Therapy and the control arm receiving Lifestyle Therapy (2:1 randomization). METHODS AT participants were permitted to continue in the study for an additional year up to a maximum of 5 years providing they maintained at least 10% total weight loss (TWL) from baseline at each year end. For AT participants who continued the study, 5 medical monitoring visits were provided at weeks 60, 68, 76, 90, and 104 and thereafter once every 13 weeks up to week 260. Exclusion criteria were a history of eating disorder or evidence of eating disorder on a validated questionnaire. Follow-up weight, quality of life, and co-morbidities were compared with the baseline levels. In addition, rates of serious adverse event, persistent fistula, withdrawal, and A-tube replacement were reported. All analyses were performed using a per-protocol analysis. RESULTS Of the 82 AT participants who completed 1 year, 58 continued to this phase of the trial. Mean baseline body mass index of these 58 patients was 41.6 ± 4.5 kg/m2. At the end of first year (at the beginning of the follow-up study), these 58 patients had a body mass index of 34.1 ± 5.4 kg/m2 and had achieved an 18.3 ± 8.0% TWL. On a per protocol basis, patients experienced 14.2%, 15.3%, 16.6%, and 18.7% TWL at 1, 2, 3, and 4 years, respectively (P < .01 for all). Forty of 58 patients (69%) achieved at least 10% TWL at 4 years or at time of study withdrawal. Improvements in quality of life scores and select cardiometabolic parameters were also maintained through 4 years. There were 2 serious adverse events reported in the second through fourth years, both of which resolved with removal or replacement of the A tube. Two persistent fistulas required surgical repair, representing approximately 2% of all tube removals. There were no clinically significant metabolic or electrolytes disorders observed, nor any evidence for development of any eating disorders. CONCLUSIONS The results of this midterm study have shown that AT is a safe, effective, and durable weight loss alternative for people with class II and III obesity and who are willing to commit to using the therapy and adhere to adjustments in eating behavior.
-
4.
Transoral outlet reduction with full thickness endoscopic suturing for weight regain after gastric bypass: a large multicenter international experience and meta-analysis.
Vargas, EJ, Bazerbachi, F, Rizk, M, Rustagi, T, Acosta, A, Wilson, EB, Wilson, T, Neto, MG, Zundel, N, Mundi, MS, et al
Surgical endoscopy. 2018;(1):252-259
-
-
Free full text
-
Abstract
BACKGROUND AND AIMS Many patients who undergo bariatric surgery will experience weight regain and effective strategies are needed to help these patients. A dilated gastrojejunal anastomosis (GJA) has been associated with weight recidivism after Roux-en-Y gastric bypass surgery (RYGB). Endoscopic transoral outlet reduction (TORe) with a full thickness endoscopic suturing device (Overstitch, Apollo Endosurgery, Austin, TX) is a minimally invasive therapeutic option. The primary aim of this project was to examine the safety and long-term efficacy data from three bariatric surgery centers and to conduct a systematic review and meta-analysis of the existing literature. METHODS Patients who underwent TORe with the Overstitch device from Jan 2013 to Nov 2016 at 3 participating bariatric surgery centers were included in the multicenter analysis. For the systematic review and meta-analysis, a comprehensive search of multiple English databases was conducted. Random effects model was used. RESULTS 130 consecutive patients across three centers underwent TORe with an endolumenal suturing device. These patients (mean age 47; mean BMI 36.8) had experienced 24.6% weight regain from nadir weight after RYGB. Average weight lost at 6, 12, and 18 months after TORe was 9.31 ± 6.7 kg (N = 84), 7.75 ± 8.4 kg (N = 70), 8 ± 8.8 kg (N = 46) (p < 0.01 for all three time points), respectively. The meta-analysis included 330 patients. The pooled weight lost at 12 months was 8.4 kg (95% CI 6.5-10.3) with no significant heterogeneity across included studies (p = 0.07). Overall, 14% of patients experienced nausea, 18% had pain and 8% required a repeat EGD. No serious adverse events reported. CONCLUSION When implemented as part of a multidisciplinary intervention, TORe using endolumenal suturing is safe, reproducible, and effective approach to manage weight recidivism after RYGB and should be utilized early in the management algorithm of these patients.
-
5.
Totally endoscopic implant to effect a gastric bypass: 12-month safety and efficacy outcomes.
Sandler, BJ, Biertho, L, Anvari, M, Rumbaut, R, Morales-Garza, LA, Torres-Barrera, G, Marceau, S, Hong, D, Smith, CD, Horgan, S
Surgical endoscopy. 2018;(11):4436-4442
Abstract
BACKGROUND Only a small percentage of candidates for bariatric surgery ever undergo a procedure for weight loss. Devices duplicating key effects of bariatric surgeries with removable, fully trans-oral implants could extend their benefits to patients unwilling to undergo anatomy-altering abdominal surgeries. METHODS Thirty-two obese subjects (mean BMI: 42.3) were enrolled in a prospective, multicenter, single-arm, feasibility trial of the first fully trans-oral endoscopic gastrointestinal bypass device. The device is a cuff attached to the distal esophagus by transmural anchors and connected to a 120-cm sleeve diverting undigested nutrients to the jejunum. Bodyweight, vital signs, adverse events, medications, HbA1c, fasting glucose, and lipids were collected at baseline and follow-up visits. Device status was endoscopically assessed every 6 months. RESULTS The fully trans-oral procedure was successful in all subjects without intraoperative adverse events or postoperative infections. Twenty-eight of 32 subjects (88%) remained implanted with continuing follow-up beyond their 12-month visit. At 12 months, the 32 subjects had lost an average of 44.8% of excess body weight, 17.6% of total body weight, 20.8 kg, and 7.5 BMI points. Weight loss depended on capture of ingesta by the esophageal cuff, with 18 of 32 subjects without visible gaps around their cuffs at the 6 month endoscopy having significantly greater EWL (53.6 vs. 33.4% in the remaining subjects, p < 0.002). Mean HbA1c and fasting glucose declined by 1.1% points and 29 mg/dL in type 2 diabetic subjects, 80% of whom had remission of their diabetes at 12 months. CONCLUSION This study demonstrates the feasibility, safety, and efficacy of a fully trans-oral gastrointestinal bypass implant. This purely endoscopic device may provide a valuable addition to the armamentarium of treatment available for the management of morbid obesity.
-
6.
Prevalence and Risk Factors for Bariatric Surgery Readmissions: Findings From 130,007 Admissions in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program.
Berger, ER, Huffman, KM, Fraker, T, Petrick, AT, Brethauer, SA, Hall, BL, Ko, CY, Morton, JM
Annals of surgery. 2018;(1):122-131
Abstract
OBJECTIVE To evaluate readmissions following laparoscopic adjustable gastric banding (LAGB), laparoscopic sleeve gastrectomy (LSG), and laparoscopic Roux-en-Y gastric bypass (LRYGB). BACKGROUND Few studies have evaluated national readmission rates for primary bariatric surgery with national, bariatric-specific data. METHODS Patients undergoing primary LAGB, LSG, or LRYGB from January 1, 2014 to December 31, 2014, at 698 centers were identified based upon Current Procedural Terminology codes. The primary outcome was 30-day readmission from date of initial operation. RESULTS A total of 130,007 patients who underwent primary bariatric surgery were identified: 7378 LAGB (5.7%), 80,646 LSG (62.0%), and 41,983 LRYGB (32.3%). A total of 5663 (4.4%) patients were readmitted within 30 days for all causes. Patients undergoing LAGB had the lowest related readmission rate of 1.4%, followed by LSG (2.8%), and LRYGB (4.9%). Of patients who had a complication, 17.9% (n = 785) were readmitted, whereas those without readmission had a complication 1.9% of the time (P < 0.001). The most common cause of a related readmission was nausea, vomiting, fluid, electrolyte, and nutritional depletion (35.4%), followed by abdominal pain (13.5%), anastomotic leak (6.4%), and bleeding (5.8%), accounting for more than 61% of readmissions. When compared with LAGB, LSG, and LRYGB had significantly higher rates of readmission (LSG: odds ratio 1.89; 95% confidence interval 1.52-2.33; LRYGB odds ratio 3.06; 95% confidence interval 2.46-3.81). CONCLUSIONS National bariatric readmissions after primary procedures were closely associated with complications, varied based on the type of procedure, and were most commonly due to nausea, vomiting, electrolyte, and nutritional depletion.
-
7.
Use of prescribed opioids before and after bariatric surgery: prospective evidence from a U.S. multicenter cohort study.
King, WC, Chen, JY, Belle, SH, Courcoulas, AP, Dakin, GF, Flum, DR, Hinojosa, MW, Kalarchian, MA, Mitchell, JE, Pories, WJ, et al
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2017;(8):1337-1346
-
-
Free full text
-
Abstract
BACKGROUND Limited evidence suggests bariatric surgery may not reduce opioid analgesic use, despite improvements in pain. OBJECTIVE To determine if use of prescribed opioid analgesics changes in the short and long term after bariatric surgery and to identify factors associated with continued and postsurgery initiated use. SETTING Ten U.S. hospitals. METHODS The Longitudinal Assessment of Bariatric Surgery-2 is an observational cohort study. Assessments were conducted presurgery, 6 months postsurgery, and annually postsurgery for up to 7 years until January 2015. Opioid use was defined as self-reported daily, weekly, or "as needed" use of a prescribed medication classified as an opioid analgesic. RESULTS Of 2258 participants with baseline data, 2218 completed follow-up assessment(s) (78.7% were female, median body mass index: 46; 70.6% underwent Roux-en-Y gastric bypass). Prevalence of opioid use decreased after surgery from 14.7% (95% CI: 13.3-16.2) at baseline to 12.9% (95% CI: 11.5-14.4) at month 6 but then increased to 20.3%, above baseline levels, as time progressed (95% CI: 18.2-22.5) at year 7. Among participants without baseline opioid use (n = 1892), opioid use prevalence increased from 5.8% (95% CI: 4.7-6.9) at month 6 to 14.2% (95% CI: 12.2-16.3) at year 7. Public versus private health insurance, more pain presurgery, undergoing subsequent surgeries, worsening or less improvement in pain, and starting or continuing nonopioid analgesics postsurgery were significantly associated with higher risk of postsurgery initiated opioid use. CONCLUSION After bariatric surgery, prevalence of prescribed opioid analgesic use initially decreased but then increased to surpass baseline prevalence, suggesting the need for alternative methods of pain management in this population.
-
8.
Randomized controlled trial comparing laparoscopic greater curvature plication versus laparoscopic sleeve gastrectomy.
Grubnik, VV, Ospanov, OB, Namaeva, KA, Medvedev, OV, Kresyun, MS
Surgical endoscopy. 2016;(6):2186-91
Abstract
BACKGROUND Laparoscopic greater curvature plication (LGCP) is a new restrictive bariatric procedure, which has a similar restrictive mechanism like laparoscopic sleeve gastrectomy (LSG) without potential risk of leak. Aim of the study was to compare 2-year outcomes of LSG and LGCP. METHODS Multicenter prospective randomized trial was started in 2010. A total of 54 patients with morbid obesity were allocated either to LGCP group (n = 25) or LSG group (n = 27). Main exclusion criteria were: ASA > III, age > 75 and BMI > 65 kg/m(2). There were 40 women and 12 men, and the mean age was 42.6 ± 6.8 years (range 35-62). Data on the operation time, complications, hospital stay, body mass index loss, percentage of excess weight loss (%EWL), loss of appetite and improvement in comorbidities were collected during the follow-up examinations. RESULTS All procedures were completed laparoscopically. The mean operative time was 92.0 ± 15 min for LSG and 73 ± 19 min for LGCP (p > 0.05). The mean hospital stay was 4.0 ± 1.9 days in the LSG group and 3.8 ± 1.7 days in LGCP group (p > 0.05). One year after surgery, the mean %EWL was 59.5 ± 15.4 % in LSG group and 45.8 ± 17 % in LGCP group (p > 0.05). After 2 years, mean %EWL was 78.9 ± 20 % in the LSG group and 42.4 ± 18 % in the LGCP group (p < 0.01). After 3 years, mean %EWL was 72.8 ± 22 in the LSG group and only 20.5 ± 23.9 in the LGCP group (p < 0.01). Loss of feeling of hunger after 2 years was 25 % in LGCP group and 76.9 % in the LSG group (p < 0.05). The comorbidities including diabetes, sleep apnea and hypertension were markedly improved in the both groups after surgery. CONCLUSION The short-term outcomes demonstrated equal effectiveness of the both procedures, but 2-year follow-up showed that LGCP is worse than LSG as a restrictive procedure for weight loss.
-
9.
Comparative results of gastric banding in adolescents and young adults.
Hervieux, E, Baud, G, Dabbas, M, Pigeyre, M, Caiazzo, R, Verhaeghe, R, Goulet, O, Aigrain, Y, Révillon, Y, Pattou, F, et al
Journal of pediatric surgery. 2016;(7):1122-5
Abstract
BACKGROUND/PURPOSE Obesity has become a major public health priority. Because of disappointing results obtained with dietary and medical programs, bariatric surgery has been offered to adolescents, although this practice remains controversial. Our aim was to evaluate laparoscopic adjustable gastric banding (LAGB) in adolescents at 2-year follow-up. MATERIAL AND METHODS This prospective study, from 2008 to 2013, compared results between adolescent patients and young adult controls. The LAGB technique and the follow-up program were similar. Weight loss and comorbid disease were analyzed. RESULTS Thirty-six adolescents (mean age at surgery=16.7±1.3years) were operated on and compared to 53 young adults (mean age at surgery=21.7±1.9years). The mean weight and BMI at surgery were 124.4±20.7 and 43.9±5.5kg/m(2), respectively. Among the adolescents, none were diabetic or hypertensive. The mean glycated hemoglobin was 5.6±1.2%. In four cases (11%) dyslipidemia was observed. There was no significant difference between the two groups in terms of initial preoperative weight or BMI. The absolute BMI values at 6, 12 and 24months after surgery were comparable between adolescents and young adults: 38.7 vs 39.8, 36.0 vs 37.6 and 33.5 vs 36.1kg/m(2), respectively. The excess weight loss was higher in adolescents at 12 and 24months: 48.6 vs 37.6% (p=0.03); and 62.3 vs 45.5% (p=0.02). During this period, insulin resistance and dyslipidemia decreased similarly in both groups. CONCLUSION Provided there is careful selection of patients and a supportive multidisciplinary team, satisfying results can be obtained after LAGB in adolescents, comparable to those obtained in young adults at 2-year follow-up.
-
10.
Closed-loop gastric electrical stimulation versus laparoscopic adjustable gastric band for the treatment of obesity: a randomized 12-month multicenter study.
Horbach, T, Meyer, G, Morales-Conde, S, Alarcón, I, Favretti, F, Anselmino, M, Rovera, GM, Dargent, J, Stroh, C, Susewind, M, et al
International journal of obesity (2005). 2016;(12):1891-1898
Abstract
OBJECTIVE To compare the weight loss, change in quality of life (QOL) and safety of closed-loop gastric electrical stimulation (CLGES) versus adjustable gastric band (LAGB) in the treatment of obesity. METHODS This multicenter, randomized, non-inferiority trial randomly assigned the patients in a 2:1 ratio to laparoscopic CLGES versus LAGB and followed them for 1 year. We enrolled 210 patients, of whom 50 were withdrawn preoperatively. Among 160 remaining patients (mean age=39±11 years; 75% women; mean body mass index=43±6 kg m-2) 106 received CLGES and 54 received LAGB. The first primary end point was non-inferiority of CLGES versus LAGB, ascertained by the proportion of patients who, at 1 year, fulfilled: (a) a ⩾20% excess weight loss (EWL); (b) no major device- or procedure-related adverse event (AE); and (c) no major, adverse change in QOL. Furthermore, ⩾50% of patients had to reach ⩾25% EWL. The incidence and seriousness of all AE were analyzed and compared using Mann-Whitney's U-test. RESULTS At 1 year, the proportions of patients who reached all components of the primary study end point were 66.7 and 73.0% for the LAGB and CLGES group, respectively, with a difference of -6.3% and an upper 95% CI of 7.2%, less than the predetermined 10% margin for confirming the non-inferiority of CLGES. The second primary end point was also met, as 61.3% of patients in the CLGES group reached ⩾25% EWL (lower 95% CI=52.0%; P<0.01). QOL improved significantly and similarly in both groups. AE were significantly fewer and less severe in the CLGES than in the LAGB group (P<0.001). CONCLUSIONS AND RELEVANCE This randomized study confirmed the non-inferiority of CLGES compared with LAGB based on the predetermined composite end point. CLGES was associated with significantly fewer major AE.