Study Results
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Basic Information
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COMPLETED
NA
256 participants
INTERVENTIONAL
2014-05-31
2018-03-31
Brief Summary
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More recently another procedure has been described which seems as efficient on weight loss and co-morbidities as the RYGBP, with the advantage of being less technically difficult and less morbid, especially for multi-complicated obese and/or the super obese. It consists of a unique gastro-jejunal anastomosis between a long gastric pouch and a jejunal Omega loop. However, this procedure could be at risk of biliary reflux and anastomotic ulcers with dysplastic changes of the gastric and esophageal mucosa. As a result, the Omega loop bypass (OLB) has only been developed by a few teams and remains a controversial subject, particularly as only one monocentric randomized trial has compared it to the RYGBP, which is remains the gold standard. The first litterature results show similar or even better weight loss efficiency than RYGBP with a better feasibility. The early complication rate seems lower, but there are still insufficient data on long term morbidity and biliary reflux consequences.
By performing a randomized and prospective comparison of OLB to RYGBP, the aim of the investigators study is to analyze the weight loss efficiency, the morbidity and mortality, the feasibility, and the quality of life of both techniques, in order to validate the Omega loop bypass as a procedure of choice in bariatric surgery
Hypothesis :
The OLB, while being as efficient as RYGBP on weight loss and metabolic complications, could be less morbid.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Laparoscopic Omega Loop Bypass
Laparoscopic Mini-gastric bypass
Laparoscopic Mini-gastric bypass
The laparoscopic Omega Loop Bypass will consist of:
* a long gastric tube, stapled approximately 1.5 cm from the left of the lesser curvature of the antrum to the angle of His
* a narrow gastric tube will be calibrated to be approximately 1.5 cm wide
* an Omega loop of 200 cm
* a unique gastro-jejunal anatomosis of 200cm from the ligament of Treitz, using a linear stapler
Laparoscopic Roux-en-Y Gastric ByPass
Procedure of reference in bariatric surgery
Procedure of reference in bariatric surgery
The laparoscopic Roux-en-Y Gastric Bypass will consist of:
* a small gastric pouch (about 30cc)
* an antecolic alimentary limb
* a gastro-jejunal anastomosis using a linear stapler
* a 150cm long alimentary limb
* a 50cm biliary limb
* a latero-lateral jejuno-jejunal anastomosis
* closure of the mesenteric defects
Interventions
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Laparoscopic Mini-gastric bypass
The laparoscopic Omega Loop Bypass will consist of:
* a long gastric tube, stapled approximately 1.5 cm from the left of the lesser curvature of the antrum to the angle of His
* a narrow gastric tube will be calibrated to be approximately 1.5 cm wide
* an Omega loop of 200 cm
* a unique gastro-jejunal anatomosis of 200cm from the ligament of Treitz, using a linear stapler
Procedure of reference in bariatric surgery
The laparoscopic Roux-en-Y Gastric Bypass will consist of:
* a small gastric pouch (about 30cc)
* an antecolic alimentary limb
* a gastro-jejunal anastomosis using a linear stapler
* a 150cm long alimentary limb
* a 50cm biliary limb
* a latero-lateral jejuno-jejunal anastomosis
* closure of the mesenteric defects
Eligibility Criteria
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Inclusion Criteria
* Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or more co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia, arthritis)
* Patient who has benefited from an upper GI endoscopy with biopsies
* Patient who has benefited from a pluridisciplinary evaluation, with a favorable opinion for a gastric bypass
* Patient who understands and accepts the need for a long term follow-up
* Patient who agrees to be included in the study and who signs the informed consent form
* Patient affiliated to a healthcare insurance plan
Exclusion Criteria
* Severe gastroesophageal reflux disease (GERD), resistant to medical treatment
* Presence of dysplastic modifications of the gastric mucosa or a history of gastric cancer, on upper gastrointestinal endoscopy.
* Presence of Helicobacter Pylori resistant to medical treatment
* Presence of an unhealed gastro-duodenal ulcer or an ulcer diagnosed less than 2 months previously
* History of previous bariatric surgery (gastric band, sleeve gastrectomy, vertical banded gastroplasty)
* Presence of a severe and evolutive life threatening pathology, unrelated to obesity
* Presence of chronic diarrhea (≥ 3 loose or liquid stools per day, over a period of more than 4 weeks)
* Pregnancy or desire to be pregnant during the study
* Binge eating disorders or other eating disorders according to DSM V criteria
* Mentally unbalanced patients, under supervision or guardianship
* Patient who does not understand French/is unable to give consent
* Patient not affiliated to a French or European healthcare insurance
* Patient who has already been included in a trial which has a conflict of interests with the present study
18 Years
65 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Maud ROBERT, MD
Role: PRINCIPAL_INVESTIGATOR
Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon - France
Locations
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Clinique Universitaire de Chirurgie Digestive et de l'Urgence - CHU de Grenoble
Grenoble, , France
Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche
Guilherand-Granges, , France
Service de Chirurgie Générale et Endocrinienne - Hôpital Claude Huriez - CHU de Lille
Lille, , France
Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, , France
Service de Chirurgie Digestive et Hépato-Bilio-Pancréatique et Transplantation Hépatique - Hôpital de la Pitié Salpêtrière
Paris, , France
Service de Chirurgie Digestive, Générale et Cancérologique - Hôpital Européen Georges Pompidou - APHP
Paris, , France
Service de Chirurgie Générale - Hôpital Privé de la Loire
Saint-Etienne, , France
Service de Chirurgie Générale, Digestive et Viscérale - Centre Hospitalier Intercommunal de Poissy / Saint Gerrmain en Laye
Saint-Germain-en-Laye, , France
Service de Chirurgie Digestive et Hépato-Biliaire-Centre Hospitalier Privé Saint Grégoire
Saint-Grégoire, , France
Countries
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References
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Robert M, Espalieu P, Pelascini E, Caiazzo R, Sterkers A, Khamphommala L, Poghosyan T, Chevallier JM, Malherbe V, Chouillard E, Reche F, Torcivia A, Maucort-Boulch D, Bin-Dorel S, Langlois-Jacques C, Delaunay D, Pattou F, Disse E. 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. Lancet. 2019 Mar 30;393(10178):1299-1309. doi: 10.1016/S0140-6736(19)30475-1. Epub 2019 Mar 6.
Robert M, Poghosyan T, Maucort-Boulch D, Filippello A, Caiazzo R, Sterkers A, Khamphommala L, Reche F, Malherbe V, Torcivia A, Saber T, Delaunay D, Langlois-Jacques C, Suffisseau A, Bin S, Disse E, Pattou F. Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass at 5 years (YOMEGA): a prospective, open-label, non-inferiority, randomised extension study. Lancet Diabetes Endocrinol. 2024 Apr;12(4):267-276. doi: 10.1016/S2213-8587(24)00035-4. Epub 2024 Mar 4.
Other Identifiers
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2014.851
Identifier Type: -
Identifier Source: org_study_id