5 and 7-year Follow-up of the YOMEGA Trial Cohort
YOMEGA 5-7y
Evaluation of the Long-term Efficacy and Safety of the Omega Loop Bypass Versus the Roux-en-Y Gastric Bypass on the Cohort of Patients Included in the Randomized Trial YOMEGA (DGOS 13-0037)
1 other identifier
observational
248
1 country
9
Brief Summary
Over the last 40 years, the Roux-en-Y Gastric Bypass (RYGB) has been the gold standard in the surgical management of morbid obesity. and is a validated bariatric procedure in France. Nevertheless, the RYGB remains a technically demanding procedure; thus and in order to overcome the complexity of this intervention, a simpler technique based on a single anastomosis at 200cm from the Treitz angle creating an omega loop (Mini Gastric Bypass - MGB or One Anastomosis Gastric Bypass-OAGB) has gradually spread around the worl without prior evaluation, . In 2018, the MGB was officially recognized by the International Federation of Bariatric Surgery (IFSO) as a standard procedure but not by the ASMBS American Society for Metabolic and Bariatric Surgery ; indeed, the OAGB remains controversial because considered by many surgeons at risk of biliary reflux and malnutrition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Typical duration for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 19, 2022
CompletedFirst Posted
Study publicly available on registry
September 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedSeptember 22, 2022
September 1, 2022
2.4 years
September 19, 2022
September 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight loss assessment
Measured according to : Excess BMI Loss percentage (EBL%), calculated using the following formula: ((BMI 5 years after surgery - initial BMI) / (initial BMI - Ideal BMI)) X 100. And : ((BMI 7 years after surgery - initial BMI) / (initial BMI - Ideal BMI)) X 100. Using 25 as ideal BMI
5 and 7 years after surgery
Study Arms (2)
Obese patients who underwent a Laparoscopic One Anastomosis Gastric Bypass (OAGB) 5 years ago
Patients (BMI \> or = 35kg/m2 +/- co-morbidities) who have been operated on using the Gastric bypass procedure built with an Omega loop of 200 cm and a unique gastro-jejunal anastomosis
Obese patients who underwent a Laparoscopic Roux-en-Y Gastric ByPass (RYGBP) 5 years ago
Patients (BMI \> or = 35kg/m2 +/- co-morbidities) who have been operated on using the Roux-en-Y gastric bypass which consists in a small gastric pouch (30cc), a 150cm alimentary limb and a 50cm biliary limb. Mesenteric defects were closed.
Interventions
The laparoscopic Omega Loop Bypass performed 5 years ago consisted 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 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
The laparoscopic Roux-en-Y Gastric Bypass performed 5 years ago consisted 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
Patients included in the YOMEGA study, randomized and operated on with the technique assigned to them (121 RYGB and 127 OLB)
You may qualify if:
- Patients included in the YOMEGA study, randomized and operated on with the technique assigned to them (121 RYGB and 127 MGB).
- Aged between 18 and 65 years old
- 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
You may not qualify if:
- Patients randomized in the YOMEGA study, not operated on with the technique assigned to them.
- History of esophagitis on upper GI endoscopy (Los Angeles classification)
- 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 (Diagnostic and Statistical Manual of Mental Disorders)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche
Guilherand-Granges, 07500, France
Service de Chirurgie Générale et Endocrinienne - Hôpital Claude Huriez - CHU de Lille
Lille, 59037, France
Service de Chirurgie Digestive Hôpital Edouard Herriot
Lyon, France
Département de Chirurgie Digestive et Hépatobiliaire - Hôpital Pitié Salpétrière
Paris, 75013, France
AP-HP Hôpîtal Europeen Georges Pompidou
Paris, 75908, France
Service de Chirurgie Digestive, Générale et Cancérologique - HEGP
Paris, 75908, France
Service de Chirurgie Générale - Hôpital Privé de la Loire
Saint-Etienne, 42100, France
Service de Chirurgie Générale, Digestive et Viscérale - Centre Hospitalier Intercommunal de Poissy / Saint Gerrmain en Laye
Saint-Germain-en-Laye, 78100, France
Département de Chirurgie Digestive et Hépatobiliaire - Centre Hospitalier Privé Saint Grégoire
Saint-Grégoire, 35760, France
Related Publications (1)
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.
PMID: 38452784DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2022
First Posted
September 22, 2022
Study Start
April 1, 2022
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
September 22, 2022
Record last verified: 2022-09