OP270 Why The Haute Autorité de Santé Rejects the Widespread Use Of “Mini-Bypass”/One Anastomosis Gastric Bypass For Obesity In France

2020 ◽  
Vol 36 (S1) ◽  
pp. 4-4
Author(s):  
Jean-Charles Lafarge ◽  
Denis-Jean David ◽  
Cédric Carbonneil
Keyword(s):  
Esophageal Cancer ◽  
Gastric Bypass ◽  
Adverse Events ◽  
Severe Obesity ◽  
One Anastomosis Gastric Bypass ◽  
Close Monitoring ◽  
Efficacy And Safety ◽  
Multicenter Rct ◽  
Nutritional Complications

IntroductionOne anastomosis gastric bypass (OAGB) has become a widespread technique over the last few years in France, without any prior assessment and despite existing controversies among bariatric surgeons. An older bypass technique for treating obesity, the Roux-en-Y gastric bypass (RYGB), is available and reimbursed, having been assessed and approved for use in 2005. In 2019, the French Haute Autorité de Santé (HAS) assessed OAGB for the treatment of severe and massive obesity. This assessment, the first in the world, was undertaken for OAGBs carried out with a 200- or 150-centimeter biliopancreatic-limb (BP-limb) length.MethodsA systematic review (SR) of the literature and consultation of a working group consisting of both healthcare professionals (clinician and surgeons) and patients were carried out. The primary aim of our assessment was to determine whether the OAGB technique can replace RYGB. The efficacy and safety profile of OAGB was compared with RYGB in adult patients with massive, severe obesity. Complications and postoperative follow up specific to OAGB were identified.ResultsThe three selected randomized controlled trials (RCTs) could not confirm the superiority or the non-inferiority of OAGB, compared with RYGB, on the selected efficacy endpoints of weight loss, resolution of comorbidities, and quality of life. Adverse events reported for OAGB included severe nutritional complications and bile reflux that could potentially lead to lower esophageal cancer. In one RCT, the frequency of serious adverse events in the OAGB group was almost two times higher than in the RYGB group.ConclusionsHAS considered that OAGB carried out with a longer (200 centimeter) BP-limb is not a validated technique for the surgical treatment of massive, severe obesity. Thus, it cannot be considered an alternative to RYGB. There were insufficient data available on OAGB performed with a 150-centimeter BP-limb. Thus, HAS recommended undertaking a multicenter RCT to assess the efficacy and safety of OAGB. Patients who have already undergone OAGB should receive the same follow up as patients who have received RYGB, including close monitoring for nutritional complications and lower esophageal cancer and an endoscopic examination five years after surgery.

scholarly journals Is One Anastomosis Gastric Bypass with a Biliopancreatic Limb of 150 cm Effective in the Treatment of People with Severe Obesity with BMI > 50?

2021 ◽  
Author(s):  
Arnaud Liagre ◽  
Francesco Martini ◽  
Radwan Kassir ◽  
Gildas Juglard ◽  
Celine Hamid ◽  
...  
Keyword(s):  
Bariatric Surgery ◽  
Weight Loss ◽  
Gastric Bypass ◽  
Severe Obesity ◽  
Postoperative Mortality ◽  
One Anastomosis Gastric Bypass ◽  
Sustained Weight Loss ◽  
Biliopancreatic Limb ◽  
Percentage Excess Weight Loss

Abstract Purpose The treatment of people with severe obesity and BMI > 50 kg/m2 is challenging. The present study aims to evaluate the short and mid-term outcomes of one anastomosis gastric bypass (OAGB) with a biliopancreatic limb of 150 cm as a primary bariatric procedure to treat those people in a referral center for bariatric surgery. Material and Methods Data of patients who underwent OAGB for severe obesity with BMI > 50 kg/m2 between 2010 and 2017 were collected prospectively and analyzed retrospectively. Follow-up comprised clinical and biochemical assessment at 1, 3, 6, 12, 18, and 24 months postoperatively, and once a year thereafter. Results Overall, 245 patients underwent OAGB. Postoperative mortality was null, and early morbidity was observed in 14 (5.7%) patients. At 24 months, the percentage total weight loss (%TWL) was 43.2 ± 9, and percentage excess weight loss (%EWL) was 80 ± 15.7 (184 patients). At 60 months, %TWL was 41.9 ± 10.2, and %EWL was 78.1 ± 18.3 (79 patients). Conversion to Roux-en-Y gastric bypass was needed in three (1.2%) patients for reflux resistant to medical treatment. Six patients (2.4%) had reoperation for an internal hernia during follow-up. Anastomotic ulcers occurred in three (1.2%) patients. Only two patients (0.8%) underwent a second bariatric surgery for insufficient weight loss. Conclusion OAGB with a biliopancreatic limb of 150 cm is feasible and associated with sustained weight loss in the treatment of severe obesity with BMI > 50 kg/m2. Further randomized studies are needed to compare OAGB with other bariatric procedures in this setting. Graphical abstract

scholarly journals Efficacy and safety of combined endoscopic cyanoacrylate injection and balloon-occluded retrograde transvenous occlusion (BRTOcc) of gastrorenal shunts in patients with bleeding gastric fundal varices

2020 ◽  
Author(s):  
Fateh Bazerbachi ◽  
Akira Dobashi ◽  
Swarup Kumar ◽  
Sanjay Misra ◽  
Navtej S Buttar ◽  
...  
Keyword(s):  
Adverse Events ◽  
Gastric Varices ◽  
High Rate ◽  
Efficacy And Safety ◽  
Cyanoacrylate Glue ◽  
Serious Adverse Events ◽  
Gastroesophageal Varices ◽  
Life Threatening ◽  
Glue Embolization

Abstract Background Endoscopic cyanoacrylate (glue) injection of fundal varices may result in life-threatening embolic adverse events through spontaneous gastrorenal shunts (GRSs). Balloon-occluded retrograde transvenous occlusion (BRTOcc) of GRSs during cyanoacrylate injection may prevent serious systemic glue embolization through the shunt. This study aimed to evaluate the efficacy and safety of a combined endoscopic–interventional radiologic (BRTOcc) approach for the treatment of bleeding fundal varices. Methods We retrospectively analysed the data of patients who underwent the combined procedure for acutely bleeding fundal varices between January 2010 and April 2018. Data were extracted for patient demographics, clinical and endoscopic findings, technical details, and adverse events of the endoscopic–BRTOcc approach and patient outcomes. Results We identified 30 patients (13 [43.3%] women; median age 58 [range, 25–92] years) with gastroesophageal varices type 2 (53.3%, 16/30) and isolated gastric varices type 1 (46.7%, 14/30) per Sarin classification, and median clinical and endoscopic follow-up of 151 (range, 4–2,513) days and 98 (range, 3–2,373) days, respectively. The median volume of octyl-cyanoacrylate: Lipiodol injected was 7 (range, 4–22) mL. Procedure-related adverse events occurred in three (10.0%) patients, including transient fever, non-life-threatening pulmonary glue embolism, and an injection-site ulcer bleed. Complete gastric variceal obturation was achieved in 18 of 21 patients (85.7%) at endoscopic follow-up. Delayed variceal rebleeding was confirmed in one patient (3.3%) and suspected in two patients (6.7%). Although no procedure-related deaths occurred, the overall mortality rate was 46.7%, primarily from liver-disease progression and co-morbidities. Conclusion The combined endoscopic–BRTOcc procedure is a relatively safe and effective technique for bleeding fundal varices, with a high rate of variceal obturation and a low rate of serious adverse events.

Short-Term Results of Single-Anastomosis Gastric Bypass After Failed Sleeve Gastrectomy

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Alaa Abbas Sabry ◽  
Karim Sabry Abd-Elsamee ◽  
Mohamed Ibrahim Mohamed ◽  
Mohammed Mohamed Ahmed Abd-Elsalam
Keyword(s):  
Weight Loss ◽  
Gastric Bypass ◽  
Sleeve Gastrectomy ◽  
Weight Regain ◽  
Revisional Surgery ◽  
One Anastomosis Gastric Bypass ◽  
Short Term ◽  
Multicenter Studies ◽  
Metabolic Outcomes

Abstract Background It is already known that Laparoscopic sleeve gastrectomy (LSG) has gained popularity as a stand-alone procedure with good short-term results for weight loss. However, in the long-term, weight regain is considered as a complication. Demand for secondary surgery is rising, partly for this reason, but through that study we try to discover the efficacy of conversion of failed sleeve gastrectomy to one anastomosis gastric bypass (OAGB) regarding weight loss and metabolic outcomes. Objective To asses the efficacy and safety of one anastomosis gastric bypass (OAGB) as a conversion surgery post Sleeve Gastrectomy failure as regard weight loss and metabolic outcomes. Patients and Methods This study is a retrospective cohort study which included 20 patients underwent one anastomosis gastric bypass at Ain-Shams University El-Demerdash Hospital, Cairo, Egypt and specialized bariatric center, Cairo, Egypt From February 2019 to July 2019 with 6 months of postoperative follow up till January 2019. Results In this study, we reviewed and analyzed the outcomes from the revision of the SG due to either inadequate weight loss or weight regain to one anastomosis gastric bypass (OAGB) with %EBWL of 6.65% at 1 month, 13.61 % at 3 months and 20.86% at 6 months. Conclusion OAGB appears to be an effective and safe therapeutic technique as a revisional surgery for failed primary SG with good short-term results for treating morbid obesity and its associated comorbidities with a significantly low rate of complications. However the EBWL was less than what is reported after primary OAGB weight. Multicenter studies with larger series of patients and longer term follow up after SG revisions to OAGB are warranted.

scholarly journals Efficacy and safety of a combined treatment of sodium stibogluconate at 20mg/kg/day with upper maximum daily dose limit of 850mg and Paromomycin 15mg/kg/day in HIV negative visceral leishmaniasis patients. A retrospective study, northwest Ethiopia

2021 ◽  
Vol 15 (8) ◽  
pp. e0009713
Author(s):  
Aschalew Tamiru ◽  
Rezika Mohammed ◽  
Saba Atnafu ◽  
Girmay Medhin ◽  
Asrat Hailu
Keyword(s):  
Visceral Leishmaniasis ◽  
Adverse Events ◽  
Combined Treatment ◽  
Daily Maximum ◽  
Sodium Stibogluconate ◽  
Efficacy And Safety ◽  
African Countries ◽  
Treatment Interruptions ◽  
Hiv Negative

Background Visceral leishmaniasis (VL) is one of the most neglected tropical infectious diseases. It is fatal if left untreated. The objective of this study was to assess the efficacy and safety of 17-day injections of combined regimen of sodium stibogluconate and paromomycin (SSG/PM) in HIV-negative VL patients. Methods A retrospective analysis of medical records of VL patients treated in the University of Gondar Hospital during period 2012–2019 was carried out. Results A total of 2836 patients were treated for VL from 2012 to 2019. Of these 1233 were treated with SSG-PM, and 1000 of them were included in the study. Initial cure was achieved in 922 (92.2%) patients. The frequency of treatment failure, treatment interruptions, default and deaths respectively were 30 (3%), 20 (2%), 13 (1.3%) and 15 (1.5%). Among 280 patients who completed 6-month follow up, the final cure was 93.9% (263/280), 4 (1.4%) relapsed and 13 (4.6%) developed post-kala-azar dermal leishmaniasis (PKDL). The most common adverse events (AEs) were raised liver transaminases (35.1%; 351 patients), injection site pain (29.1%, 291 patients) and raised serum alpha-amylase (29.1%, 291 patients). Factors associated with poor treatment outcomes were sepsis, pneumonia, and adverse events. Conclusion A combination of SSG at 20mg/kg with upper daily maximum dose of 850mg and PM was effective for achieving initial cure at end of treatment and safe for treatment of HIV negative VL patients in northwestern Ethiopia. Our data are consistent with previous reports and confirms effectiveness of SSG/PM treatment regimen in the Eastern African countries. Efficacy at 6-months (93.9%) was estimated on data derived from patients who completed follow up and needs to be interrogated by future studies.

scholarly journals Bile Reflux is a Common Finding in the Gastric Pouch After One Anastomosis Gastric Bypass

2019 ◽  
Vol 30 (3) ◽  
pp. 875-881 ◽  
Author(s):  
Tuure Saarinen ◽  
Kirsi H. Pietiläinen ◽  
Antti Loimaala ◽  
Toni Ihalainen ◽  
Henna Sammalkorpi ◽  
...  
Keyword(s):  
Gastric Bypass ◽  
De Novo ◽  
Bile Reflux ◽  
Gastric Pouch ◽  
Total Activity ◽  
One Anastomosis Gastric Bypass ◽  
Common Finding ◽  
Upper Gastrointestinal Endoscopy ◽  
Long Term Effects

Abstract Introduction Data on postoperative bile reflux after one anastomosis gastric bypass (OAGB) is lacking. Bile reflux scintigraphy (BRS) has been shown to be a reliable non-invasive tool to assess bile reflux after OAGB. We set out to study bile reflux after OAGB with BRS and endoscopy in a prospective series (RYSA Trial). Methods Forty patients (29 women) underwent OAGB between November 2016 and December 2018. Symptoms were reported and upper gastrointestinal endoscopy (UGE) was done preoperatively. Six months after OAGB, bile reflux was assessed in UGE findings and as tracer activity found in gastric tube and esophagus in BRS (follow-up rate 95%). Results Twenty-six patients (68.4%) had no bile reflux in BRS. Twelve patients (31.6%) had bile reflux in the gastric pouch in BRS and one of them (2.6%) had bile reflux also in the esophagus 6 months postoperatively. Mean bile reflux activity in the gastric pouch was 5.2% (1–21%) of total activity. De novo findings suggestive of bile reflux (esophagitis, stomal ulcer, foveolar inflammation of gastric pouch) were found for 15 patients (39.5%) in postoperative UGE. BRS and UGE findings were significantly associated (P = 0.022). Eight patients experienced de novo reflux symptoms at 6 months, that were significantly associated with BRS and de novo UGE findings postoperatively (P = 0.033 and 0.0005, respectively). Conclusion Postoperative bile reflux in the gastric pouch after OAGB is a common finding in scintigraphy and endoscopy. The long-term effects of bile exposure will be analyzed in future reports after a longer follow-up. Trial registration Clinical Trials Identifier NCT02882685

Iron chelation with deferasirox in adult and pediatric patients with thalassemia major: efficacy and safety during 5 years' follow-up

Blood ◽  
2011 ◽  
Vol 118 (4) ◽  
pp. 884-893 ◽  
Author(s):  
M. Domenica Cappellini ◽  
Mohamed Bejaoui ◽  
Leyla Agaoglu ◽  
Duran Canatan ◽  
Marcello Capra ◽  
...  
Keyword(s):  
Adverse Events ◽  
Iron Concentration ◽  
Iron Chelation ◽  
Dry Weight ◽  
Thalassemia Major ◽  
Efficacy And Safety ◽  
Liver Iron ◽  
Median Serum

Abstract Patients with β-thalassemia require lifelong iron chelation therapy from early childhood to prevent complications associated with transfusional iron overload. To evaluate long-term efficacy and safety of once-daily oral iron chelation with deferasirox, patients aged ≥ 2 years who completed a 1-year, phase 3, randomized trial entered a 4-year extension study, either continuing on deferasirox (deferasirox cohort) or switching from deferoxamine to deferasirox (crossover cohort). Of 555 patients who received ≥ 1 deferasirox dose, 66.8% completed the study; 43 patients (7.7%) discontinued because of adverse events. In patients with ≥ 4 years' deferasirox exposure who had liver biopsy, mean liver iron concentration significantly decreased by 7.8 ± 11.2 mg Fe/g dry weight (dw; n = 103; P < .001) and 3.1 ± 7.9 mg Fe/g dw (n = 68; P < .001) in the deferasirox and crossover cohorts, respectively. Median serum ferritin significantly decreased by 706 ng/mL (n = 196; P < .001) and 371 ng/mL (n = 147; P < .001), respectively, after ≥ 4 years' exposure. Investigator-assessed, drug-related adverse events, including increased blood creatinine (11.2%), abdominal pain (9.0%), and nausea (7.4%), were generally mild to moderate, transient, and reduced in frequency over time. No adverse effect was observed on pediatric growth or adolescent sexual development. This first prospective study of long-term deferasirox use in pediatric and adult patients with β-thalassemia suggests treatment for ≤ 5 years is generally well tolerated and effectively reduces iron burden. This trial was registered at www.clinicaltrials.gov as #NCT00171210.

scholarly journals The Early Results of the Laparoscopic Mini-Gastric Bypass/One Anastomosis Gastric Bypass on Patients with Different Body Mass Index

2020 ◽  
Vol 2020 ◽  
pp. 1-6 ◽  
Author(s):  
Mohsen Mahmoudieh ◽  
Behrouz Keleidari ◽  
Naser Afshin ◽  
Masoud Sayadi Shahraki ◽  
Shahab Shahabi Shahmiri ◽  
...  
Keyword(s):  
Body Mass Index ◽  
Weight Loss ◽  
Gastric Bypass ◽  
Vitamin B12 ◽  
Body Mass ◽  
Excess Weight Loss ◽  
Excess Weight ◽  
One Anastomosis Gastric Bypass ◽  
Mini Gastric Bypass

Introduction. Obesity is among the newest health matters that human beings are struggling with. Length of bypassed intestine is important in achievement of most weight loss and least nutritional and absorptive disorders. This study has aimed to assess short-term metabolic and nutritional effects of laparoscopic mini-gastric bypass/one anastomosis gastric bypass (MGB/OAGB) with a loop bypass length of 180 centimeters (cm) and compare these factors among patients with a body mass index (BMI) of 40–45 and 45–50 kilograms per square meter (kg/m2). Methods. 25 patients were put in group 1 (BMI = 40–45 kg/m2) and 25 patients in group 2 (BMI = 45–50 kg/m2). Patients’ BMI, postoperative weight, excess weight loss, and laboratory tests including fasting blood sugar (FBS), lipid profile, serum iron (Fe), ferritin, total iron-binding capacity (TIBC), 25-OH vitamin D, vitamin B12, liver function tests, and albumin were recorded preoperatively and within 3- and 6-month follow-up. Results. Weight loss and BMI reduction was significantly more in patients with higher BMI level (P=0.007), and excess weight loss was higher in patients with lower preoperative BMI level (P=0.007). Six-month follow-up showed statistically significant reduction in total cholesterol, total triglyceride, Fe, and vitamin B12 among patients with higher BMI level (P value <0.05). Conclusion. Based on this study, 180-cm intestinal bypassed length works for patients with a BMI level of 40–45 and 45–50 kg/m2, according to their significant decrease in weight, BMI, and improving glycolipid profile.

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