Omega Gastric Bypass (150cm) Compared to the Roux-en-Y Gastric Bypass (YOMEGA-2 Multicentric Trial)

NCT ID: NCT06057597

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 368 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-13
• Study Completion Date: 2028-12-01

Brief Summary

Obesity with its consequences such as type 2 diabetes, high blood pressure, dyslipidemia, fatty liver disease, sleep apnea and cancers, remains a major healthcare problem worldwide. Bariatric surgery, combined with nutritional education and close monitoring, has been shown to be the most effective treatment for patients with morbid obesity resulting in significant and lasting weight loss and improvements in co-morbidities . With nearly 50000 procedures per year France ranks third in the world in terms of care for patients suffering from morbid (BMI ≥ 40 kg/m²) and severe (BMI 35-40 kg/m²) obesity.

In parallel with the significant increase in the number of patients operated on for obesity in the world, over the past two decades, significant development has been observed in the field of bariatric surgery with a decrease or even disappearance of some procedures and the appearance of others.

Performed for more than 40 years, the Roux-en-Y Gastric Bypass (RYGB) is a restrictive and malabsorptive procedure and currently is considered as gold standard procedure for the treatment of morbid obesity and its comorbidities. However, despite the good effectiveness (with an average Excess Weight Loss % (EWL%) of approximatively 70% at 2 years), RYGB is technically demanding procedure with learning curve requiring more than 100 cases and an overall complication rate ranging from 10% to 20% Introduced in 2001, one anastomosis gastric bypass (OAGB) is a modified gastric bypass that consists of a single gastrojejunal anastomosis between a long gastric pouch and a jejunal (biliopancreatic) omega loop. In Sept. 2019, taking into account the results from YOMEGA trial, the French High Authority for Health (Haute Autorité de Santé (HAS)) recommended to ban OAGB with 200 cm or longer BPL and urged to assess the efficacy and safety of OAGB with 150 cm BPL in a randomized controlled trial. Indeed, YOMEGA-2 trial is logical continuity of the YOMEGA trial.

The aim of this study is to assess weight loss efficiency and the nutritional safety of the OAGB-150 in comparison to a standard (RYGB).

The hypothesis of this study is that the OAGB with a 150 cm BPL could have the same efficacy on weight loss and nutritional complication rate in comparison to the RYGB at 2 years.

Conditions

Obesity; Morbid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

This corresponds to patients with type 2 obesity (BMI 35-40) with comorbidities (high blood pressure, type 2 diabetes mellitus, obstructive sleep apnea, dyslipidemia, arthrosis) and type 3 obesity (BMI ≥ 40 kg/m²) and candidates for bariatric surgery.

Laparoscopic OAGB will be performed with long and narrow gastric pouch (30cc) and 150 cm biliopancreatic limb

Group Type: EXPERIMENTAL

Laparoscopic OAGB

Intervention Type: PROCEDURE

It is a gastric bypass surgery with a unique gastro-jejunal anastomosis, a long (11-14cm) and narrow (3-4cm) gastric pouch will be created by applying one horizontal 45-mm stapler at the angle of lesser curvature, just above the left branch of the crow's foot, and then four to five vertical 60-mm staple cartridges will be placed upwards to the angle of His, and calibrated along a 32-Fr bougie. Sectioning of the greater omentum into a bivalve will be performed. The jejunum will be measured using pre-measured strip and amounted antecolically at 150 cm from the ligament of Treitz. An end-to-side anastomosis will be performed with the gastric pouch, using a 45-mm linear stapler and an anterior running suture to close gastro-enterotomy.

Control Groupe

This corresponds to patients with type 2 obesity (BMI 35-40) with comorbidities (high blood pressure, type 2 diabetes mellitus, obstructive sleep apnea, dyslipidemia, arthrosis) and type 3 obesity (BMI ≥ 40 kg/m²) and candidates for bariatric surgery.

Standard laparoscopic RYGB will be performed with a gastric pouch (30cc) and 150 cm antecolic Roux limb and a 50 cm biliopancreatic limb.

Group Type: ACTIVE_COMPARATOR

Laparoscopic RYGB

Intervention Type: PROCEDURE

A small gastric pouch (30cc) will be created using a linear stapler. The alimentary limb will be moved up into an antecolic position after an epiploic transection so as to perform the gastro-jujunal anastomosis. The gastro-jejunostomy will be performed manually or using a linear or circular stapler. An alimentary limb of 150 cm and a biliary limb of 50cm will be measured (using premeasured strip) in order to perform the latero-lateral jejuno-jejunal anastomosis using a linear stapler. All mesenteric defects (Petersen's space and mesenteric defect) will be closed with a non-absorbable running suture

Interventions

Laparoscopic OAGB

It is a gastric bypass surgery with a unique gastro-jejunal anastomosis, a long (11-14cm) and narrow (3-4cm) gastric pouch will be created by applying one horizontal 45-mm stapler at the angle of lesser curvature, just above the left branch of the crow's foot, and then four to five vertical 60-mm staple cartridges will be placed upwards to the angle of His, and calibrated along a 32-Fr bougie. Sectioning of the greater omentum into a bivalve will be performed. The jejunum will be measured using pre-measured strip and amounted antecolically at 150 cm from the ligament of Treitz. An end-to-side anastomosis will be performed with the gastric pouch, using a 45-mm linear stapler and an anterior running suture to close gastro-enterotomy.

Intervention Type: PROCEDURE

Laparoscopic RYGB

A small gastric pouch (30cc) will be created using a linear stapler. The alimentary limb will be moved up into an antecolic position after an epiploic transection so as to perform the gastro-jujunal anastomosis. The gastro-jejunostomy will be performed manually or using a linear or circular stapler. An alimentary limb of 150 cm and a biliary limb of 50cm will be measured (using premeasured strip) in order to perform the latero-lateral jejuno-jejunal anastomosis using a linear stapler. All mesenteric defects (Petersen's space and mesenteric defect) will be closed with a non-absorbable running suture

Intervention Type: PROCEDURE

Other Intervention Names

One Anastomosis Gastric Bypass / Mini Gastric Bypass; Roux-en-Y Gastric Bypass

Eligibility Criteria

Inclusion Criteria

• Patient aged from 18 to 65 years old
• Type III obesity (BMI ≥ 40 kg/m²), or Type II obesity BMI 35-40 kg/m2 associated with at least one co-morbidity which will be improved by surgery (high blood pressure, type 2 diabetes mellitus, obstructive sleep apnea, dyslipidemia, arthrosis)
• Patient who had benefited from an Upper GI Endoscopy with biopsies to look for Helicobacter pylori within 12 months before surgery
• Patient who has benefited from a multidisciplinary evaluation at least 6 months, with a favorable opinion for a gastric bypass
• Patient who understood and accepted the need for a long-term follow-up
• Patient who agreed to be included in the study and who signed the informed consent form
• Patient affiliated to a social security scheme
• For child-bearing aged women, efficient contraception

Exclusion Criteria

• History of previous bariatric surgery
• History of chronic inflammatory bowel disease
• Presence of chronic diarrhea
• Presence of a severe and evolutive life threatening pathology
• Presence of dysplastic modifications of the gastric mucosa, chronic atrophic gastritis or history of gastric cancer
• Presence of an unhealed gastro-duodenal ulcer
• Presence of Helicobacter pylori resistant to medical treatment
• Presence of esophagitis
• Pregnancy or desire to be pregnant during the study
• Mentally unbalanced patients, under supervision or guardianship
• Patients who don't understand French and not able to give consent
• Patient included and followed in another interventional trial
• Unable to consent, under tutelage or curatorship, or judiciary safeguard

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tigran POGHOSYAN, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Bichat (APHP)

Locations

Hôpital Bichat Claude-Bernard

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Tigran POGHOSYAN, MD-PhD

Role: CONTACT

tigran.poghosyan@aphp.fr

33 1 40 25 82 39

Other Identifiers

APHP211050

Identifier Type: -

Identifier Source: org_study_id