Omega Loop Versus Roux-en-Y Gastric Bypass

NCT02139813 | Completed

• 1 other identifier: 2014.851
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 9

Brief Summary

Several prospective trials and metaanalysis have demonstrated the superiority of bariatric surgery on the medical treatment of obesity. The Roux-en-Y Gastric ByPass (RYGBP) procedure has been practiced for more than 30 years, and is the procedure of choice for morbidly obese with metabolic disorders in most of the reference centers. Nevertheless, the RYGBP is a technically demanding procedure with a learning curve of more than 75 cases. The complication rate is around 10% in expert centers. 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.

Conditions

Obesity

Keywords

Obesity -; Bariatric surgery; Gastric bypass

Outcome Measures

Primary Outcomes (1)

• Weight loss assessment according to Excess BMI Loss percentage (EBL%)

  Weight loss assessment according to Excess BMI Loss percentage (EBL%), calculated using the following formula: ((BMI 2 years after surgery - initial BMI) / (initial BMI - 22.5)) X 100

  2 years after surgery

Secondary Outcomes (13)

• Weight loss according to absolute weight loss (aWL in kg), Excess Weight Loss percentage (EWL%), EBL%

  1, 3, 6, 12, 18 and 24 months after surgery

• Waist size reduction according to absolute waist size (in cm)

  1, 3, 6, 12, 18 and 24 months after surgery

• Medical and surgical complication rates

  1, 12 and 24 months after surgery

• Type and severity of complications

  During the month following surgery (for early complications) and from one month to 24 months postoperatively (for late complications)

• Operative time

  Recorded on the day of surgery (Day 0)

Study Arms (2)

Laparoscopic Omega Loop Bypass

EXPERIMENTAL

Laparoscopic Mini-gastric bypass

Procedure: Laparoscopic Mini-gastric bypass

Laparoscopic Roux-en-Y Gastric ByPass

ACTIVE COMPARATOR

Procedure of reference in bariatric surgery

Procedure: Procedure of reference in bariatric surgery

Interventions

Laparoscopic Mini-gastric bypass PROCEDURE

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 Omega Loop Bypass

Procedure of reference in bariatric surgery PROCEDURE

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

Laparoscopic Roux-en-Y Gastric ByPass

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (9)

Clinique Universitaire de Chirurgie Digestive et de l'Urgence - CHU de Grenoble

Grenoble, 38043, France

Location

Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche

Guilherand-Granges, 07500, France

Location

Service de Chirurgie Générale et Endocrinienne - Hôpital Claude Huriez - CHU de Lille

Lille, 59037, France

Location

Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon

Lyon, 69437, France

Location

Service de Chirurgie Digestive et Hépato-Bilio-Pancréatique et Transplantation Hépatique - Hôpital de la Pitié Salpêtrière

Paris, 75013, France

Location

Service de Chirurgie Digestive, Générale et Cancérologique - Hôpital Européen Georges Pompidou - APHP

Paris, 75908, France

Location

Service de Chirurgie Générale - Hôpital Privé de la Loire

Saint-Etienne, 42100, France

Location

Service de Chirurgie Générale, Digestive et Viscérale - Centre Hospitalier Intercommunal de Poissy / Saint Gerrmain en Laye

Saint-Germain-en-Laye, 78100, France

Location

Service de Chirurgie Digestive et Hépato-Biliaire-Centre Hospitalier Privé Saint Grégoire

Saint-Grégoire, 35768, France

Location

Related Publications (2)

• 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.

  PMID: 30851879 RESULT

• 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: 38452784 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Maud ROBERT, MD

  Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon - France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 15, 2014
• Study Start: May 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (9)