ObesityYOMEGA-2NCT06057597
Omega Gastric Bypass (150cm) Compared to the Roux-en-Y Gastric Bypass (YOMEGA-2 Multicentric Trial)
A study testing Laparoscopic OAGB and Laparoscopic RYGB in people with Obesity and Morbid, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Laparoscopic OAGB and Laparoscopic RYGB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2023to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
- Presence of type 1 diabetes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Controlled Non-inferiority Trial Evaluating the Safety and Efficacy of the Omega Gastric Bypass With 150 cm Biliopancreatic Loop Length Compared to the Roux-en-Y Gastric Bypass
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.
Read more
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.
- Being tested
- Laparoscopic OAGB, Laparoscopic RYGB
- Keywords
- Bariatric surgery, RYGB, MGB/OAGB
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic OAGBProcedure or surgery
Also called One Anastomosis Gastric Bypass / Mini Gastric Bypass
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.
Laparoscopic RYGBProcedure or surgery
Also called Roux-en-Y Gastric Bypass
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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 Receives: Procedure: Laparoscopic OAGB |
| Control Groupe | Active comparator | 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. Receives: Procedure: Laparoscopic RYGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that OAGB with 150 cm biliopancreatic limb is not inferior to RYGB on weight loss (efficacy).
For each patient co-primary endpoints will be assessed at 2 years after surgery composed by:
Efficacy: Weight loss according to Excess Weight Loss % (EWL%) calculated using the following formula: ((weight 2 years after surgery - initial weight) / (initial weight - ideal weight)) x 100. Ideal weight defined as the weight corresponding to a BMI = 25 kg/m².
The assessment of the primary co-endpoint will be standardized between the sites.
Measured: 2 years after the surgery
To demonstrate that OAGB with 150 cm biliopancreatic limb is not inferior to RYGB on nutritional complication rate (safety)
For each patient co-primary endpoints will be assessed at 2 years after surgery composed by:
Safety: Nutritional complications defined by at least one vitamin deficiency (vit. B1 < 66nmol/l or B12 < 145pmol/l), malnutrition (albumin < 30g/l), anemia (hemoglobin < 10g/dl) or a combination of these.
The assessment of the primary co-endpoint will be standardized between the sites.
Measured: 2 years after the surgery
Secondary outcomes (43)
Measurement of albumin
Measurement of albumin will explore the nutritional status of patients. Results will be expressed in g/l
Measured: Before and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of pre-albumin
Measurement of pre-albumin will explore the nutritional status of patients. Results will be expressed in g/l
Measured: Before and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of hemoglobin
Measurement of hemoglobin will explore the nutritional status of patients. Results will be expressed in g/l
Measured: Before and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of calcium
Measurement of calcium will explore the nutritional status of patients. Results will be expressed in mmol/l
Measured: Before and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of ferritin
Measurement of ferritin will explore the nutritional status of patients. Results will be expressed in μg/l
Measured: Before and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of iron
Measurement of iron will explore the nutritional status of patients. Results will be expressed in mmol/l
Measured: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of % of transferrin saturation
Measurement of % of transferrin saturation will explore the nutritional status of patients. Results will be expressed in %
Measured: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of zinc
Measurement of zinc will explore the nutritional status of patients. Results will be expressed in mmol/L
Measured: Before surgery and 6, 12 months and 24 months after surgery
Measurement of vitamin A
Measurement of vitamin A will explore the nutritional status of patients. Results will be expressed in mmol/l
Measured: Before surgery and 6, 12 and 24 months after surgery
Measurement of vitamin B1
Measurement of vitamin B1 will explore the nutritional status of patients. Results will be expressed in nmol/l
Measured: Before surgery and 6, 12 and 24 months after surgery
Measurement of vitamin B9
Measurement of vitamin B9 will explore the nutritional status of patients. Results will be expressed in nmol/l
Measured: Before surgery and 6, 12 and 24 months after surgery
Measurement of vitamin B12
Measurement of vitamin B12 will explore the nutritional status of patients. Results will be expressed in pmol/l
Measured: Before surgery and 6, 12 and 24 months after surgery
Measurement of vitamin E
Measurement of vitamin E will explore the nutritional status of patients. Results will be expressed in mmol/l
Measured: Before surgery and 6, 12 and 24 months after surgery
Measurement of vitamin D
Measurement of vitamin D will explore the nutritional status of patients. Results will be expressed in nmol/l
Measured: Before surgery and 6, 12 and 24 months after surgery
Measurement of prothrombin rate
Measurement of prothrombin rate will explore the nutritional status of patients. Results will be expressed in %
Measured: Before surgery and 6, 12 and 24 months after surgery
Measurement of the 24-hour steatorrhea rate
Measurement of the average number of stool will explore the nutritional status of patients. Results will be expressed in number of stool/day
Measured: 6 month after surgery
Measurement of HbA1c
Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in %
Measured: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of fasting glycemia
Measurement of fasting glycemia will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Measured: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of HDL
Measurement of HDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Measured: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of LDL
Measurement of LDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Measured: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of cholesterol
Measurement of cholesterol will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Measured: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of triglycerides
Measurement of triglycerides will explore the Metabolic of surgery. Results will be expressed in mmol/l
Measured: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Evaluation of antidiabetic drugs
Assessment of number of antidiabetic medications will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.
Measured: Before surgery and 6, 12 and 24 months after surgery
Evaluation of antilipidemic drugs
Assessment of the number of antilipidemic medications will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment
Measured: Before surgery and 6, 12 and 24 months after surgery
Evaluation of antihypertensive drugs
Assessment of the number of antihypertensive medications will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.
Measured: Before surgery and 6, 12 and 24 months after surgery
Evaluation of the use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea
Evolution of the use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of the use or discontinuation of the use of Continuous Positive Airway Pressure machine
Measured: Before surgery and 6, 12 and 24 months after surgery
Hospitalization length
The Length of stay (in days) is based on the number of days of hospitalization from surgery (day of surgery = D0) until the end of hospitalization.
Measured: The last day of hospitalization
Number of patients readmitted
Number of patients readmitted within 30 days after surgery.
Measured: 30 days after surgery
Occurrence of kidney stone
For each visit after the surgery, the presence or not of kidney stones will be documented and if applicable the treatment will be noted
Measured: Within 2 years after surgery
Overall complications rate
Rate of medical and surgical (> or = grade III) complications within 24 months after surgery using the Dindo-Clavien classification, described as :
Grade I = Any deviation from the normal postoperative course. Grade II = Requiring pharmacological treatment with drugs other than such allowed for grade I complications.
Grade III = Requiring surgical, endoscopic or radiological intervention, not under (Grade IIIa) or under general anesthesia (Grade IIIb) Grade IV = Life-threatening complication with single organ (Grade IVa) or Multiorgan dysfunction (Grade IVb) Grade V = Death of a patient.
Measured: Within 24 months after surgery
Type of early complications
Type (medical or surgical) of early complications (within 30 days) for each procedure.
Measured: Within 30 days after surgery
Severity of early complications
Severity of early complications (within 30 days) for each procedure according to the Dindo-Clavien classification
Measured: Within 30 days after surgery
Type of late complications
Type (medical or surgical) of late complications (after 30 days) for each procedure.
Measured: Within 2 years after surgery
Severity of late complications
Severity of late complications (after 30 days) for each procedure according to the Dindo-Clavien classification
Measured: Within 2 years after surgery
Gastroesophageal reflux assessment
Evolution of gastroesophageal reflux will be assessed at each study visit, before and after surgery. This outcome will be expressed in terms of improvement, aggravation or onset.
Measured: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Absolute weight loss assessment
Weight loss at 1, 3, 6, 12, 18 and 24 months after surgery, according to absolute weight loss (aWL) in kg.
Measured: 1, 3, 6, 12, 18 and 24 months after surgery
Excess Weight Loss percentage assessment
Weight loss at 1, 3, 6, 12, 18 and 24 months after surgery, according to Excess Weight Loss percentage (EWL%), calculated using the following formula:
((weight at visit X - initial weight) / (initial weight - ideal weight)) X 100
Measured: 1, 3, 6, 12, 18 and 24 months after surgery
Excess BMI Loss percentage assessment
Weight loss at 1, 3, 6, 12, 18 and 24 months after surgery, according Excess BMI Loss percentage (EBL%), according to the formula :
((BMI at visit X - initial BMI) / (initial BMI - ideal BMI)) X 100 with Ideal BMI = 25 kg/m²
Measured: 1, 3, 6, 12, 18 and 24 months after surgery
Quality of life assessed with GIQLI questionnaire
This questionnaire consists of 36 items exploring 5 dimensions or subscales: symptoms, physical condition, emotions, social integration and the effect of any medical treatment. For each item, 5 responses will be proposed to the patients and for each answer, a score ranging from 0 to 4 (highest score = 144) will be assigned. A high score defines a more favorable health state
Measured: Before surgery and at 6, 12 and 24 months after surgery
Quality of life assessed with SF36 questionnaire
This questionnaire taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/tiredness, and general health perceptions. It also includes a single item that provides an indication of a perceived change in health
Measured: Before surgery and at 6, 12 and 24 months after surgery
Quality of life assessed with Sigstad questionnaire
The Sigstad questionnaire allows the identification and diagnosis of postoperative dumping syndrome and early hypoglycaemia: a score >7 suggests a dumping syndrome
Measured: Before surgery and at 1, 3, 6, 12, 18 and 24 months after surgery
Body composition
Body composition level on a subsample of the total population:
By impedancemetry :
- Muscle mass index in kg/m2
- Non-fat mass index in kg/m2
- Fat mass index in kg/m2
Measured: Before and 24 months after surgery.
Sarcopenia level
Sarcopenia level on a subsample of the total population will be assessed by Handgrip Strength
Measured: Before and 24 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start13 Nov 2023
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tigran POGHOSYAN, MD-PhD, Principal investigator, Bichat (APHP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057597
- Sponsor's protocol ID
- APHP211050
- Acronym
- YOMEGA-2
- Status last verified
- Nov 2025
- First submitted
- 3 Apr 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Non-inferiority Trial Evaluating the Safety and Efficacy of the Omega Gastric Bypass With 150 cm Biliopancreatic Loop Length Compared to the Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT06057597
- Acronym / sponsor ID
- YOMEGA-2 / APHP211050
- Keywords
- Bariatric surgery, RYGB, MGB/OAGB
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Laparoscopic OAGBThis 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 |
| Control Groupe | Active comparator | Procedure: Laparoscopic RYGBThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic OAGBAlso: One Anastomosis Gastric Bypass / Mini Gastric BypassIt 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. | Procedure or surgery | Experimental group |
| Laparoscopic RYGBAlso: Roux-en-Y Gastric BypassA 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 | Procedure or surgery | Control Groupe |
Primary outcome
To demonstrate that OAGB with 150 cm biliopancreatic limb is not inferior to RYGB on weight loss (efficacy).
Time frame: 2 years after the surgery
For each patient co-primary endpoints will be assessed at 2 years after surgery composed by: Efficacy: Weight loss according to Excess Weight Loss % (EWL%) calculated using the following formula: ((weight 2 years after surgery - initial weight) / (initial weight - ideal weight)) x 100. Ideal weight defined as the weight corresponding to a BMI = 25 kg/m². The assessment of the primary co-endpoint will be standardized between the sites.
To demonstrate that OAGB with 150 cm biliopancreatic limb is not inferior to RYGB on nutritional complication rate (safety)
Time frame: 2 years after the surgery
For each patient co-primary endpoints will be assessed at 2 years after surgery composed by: Safety: Nutritional complications defined by at least one vitamin deficiency (vit. B1 < 66nmol/l or B12 < 145pmol/l), malnutrition (albumin < 30g/l), anemia (hemoglobin < 10g/dl) or a combination of these. The assessment of the primary co-endpoint will be standardized between the sites.
43 secondary outcomes
Measurement of albumin
Time frame: Before and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of pre-albumin
Time frame: Before and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of hemoglobin
Time frame: Before and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of calcium
Time frame: Before and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of ferritin
Time frame: Before and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of iron
Time frame: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of % of transferrin saturation
Time frame: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of zinc
Time frame: Before surgery and 6, 12 months and 24 months after surgery
Measurement of vitamin A
Time frame: Before surgery and 6, 12 and 24 months after surgery
Measurement of vitamin B1
Time frame: Before surgery and 6, 12 and 24 months after surgery
Measurement of vitamin B9
Time frame: Before surgery and 6, 12 and 24 months after surgery
Measurement of vitamin B12
Time frame: Before surgery and 6, 12 and 24 months after surgery
Measurement of vitamin E
Time frame: Before surgery and 6, 12 and 24 months after surgery
Measurement of vitamin D
Time frame: Before surgery and 6, 12 and 24 months after surgery
Measurement of prothrombin rate
Time frame: Before surgery and 6, 12 and 24 months after surgery
Measurement of the 24-hour steatorrhea rate
Time frame: 6 month after surgery
Measurement of HbA1c
Time frame: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of fasting glycemia
Time frame: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of HDL
Time frame: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of LDL
Time frame: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of cholesterol
Time frame: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Measurement of triglycerides
Time frame: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Evaluation of antidiabetic drugs
Time frame: Before surgery and 6, 12 and 24 months after surgery
Evaluation of antilipidemic drugs
Time frame: Before surgery and 6, 12 and 24 months after surgery
Evaluation of antihypertensive drugs
Time frame: Before surgery and 6, 12 and 24 months after surgery
Evaluation of the use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea
Time frame: Before surgery and 6, 12 and 24 months after surgery
Hospitalization length
Time frame: The last day of hospitalization
Number of patients readmitted
Time frame: 30 days after surgery
Occurrence of kidney stone
Time frame: Within 2 years after surgery
Overall complications rate
Time frame: Within 24 months after surgery
Type of early complications
Time frame: Within 30 days after surgery
Severity of early complications
Time frame: Within 30 days after surgery
Type of late complications
Time frame: Within 2 years after surgery
Severity of late complications
Time frame: Within 2 years after surgery
Gastroesophageal reflux assessment
Time frame: Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery
Absolute weight loss assessment
Time frame: 1, 3, 6, 12, 18 and 24 months after surgery
Excess Weight Loss percentage assessment
Time frame: 1, 3, 6, 12, 18 and 24 months after surgery
Excess BMI Loss percentage assessment
Time frame: 1, 3, 6, 12, 18 and 24 months after surgery
Quality of life assessed with GIQLI questionnaire
Time frame: Before surgery and at 6, 12 and 24 months after surgery
Quality of life assessed with SF36 questionnaire
Time frame: Before surgery and at 6, 12 and 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tigran POGHOSYAN, MD-PhD principal investigator
Bichat (APHP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic OAGB and Laparoscopic RYGB in people with Obesity and Morbid, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tigran POGHOSYAN, MD-PhD (33 1 40 25 82 39, tigran.poghosyan@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate that OAGB with 150 cm biliopancreatic limb is not inferior to RYGB on weight loss (efficacy). (time frame: 2 years after the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.