ObesityYOMEGA 5-7yNCT05549271
5 and 7-year Follow-up of the YOMEGA Trial Cohort
An observational study of Obesity, run by Hospices Civils de Lyon at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Laparoscopic Mini-gastric bypass and Laparoscopic Roux-en-Y Gastric ByPass (RYGBP)
- Type of treatment
- Surgery or procedure
- How many people
- 248 participants
- Where
- 9 sitesFrance
- Study dates
- 1 Apr 2022to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients included in the YOMEGA study, randomized and operated on with the technique assigned to them (121 RYGB and 127 OLB)
Who may be able to join
- Patients included in the YOMEGA study, randomized and operated on with the technique assigned to them (121 RYGB and 127 MGB).
- The main inclusion criteria for the YOMEGA study were:
- 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
Show all 9Show fewer
- 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
Who cannot join
- Patients randomized in the YOMEGA study, not operated on with the technique assigned to them.
- Main non-inclusion criteria for the YOMEGA study:
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche
Guilherand-Granges, 07500
Vincent MALHERBE, MD
Vincent MALHERBE, MD
- Recruiting
Service de Chirurgie Générale et Endocrinienne - Hôpital Claude Huriez - CHU de Lille
Lille, 59037
François PATTOU, MD
François PATTOU, MD
- Recruiting
Service de Chirurgie Digestive Hôpital Edouard Herriot
Lyon
Maud ROBERT, MD, +33.4.72.11.62.63, maud.robert@chu-lyon.fr
- Recruiting
Département de Chirurgie Digestive et Hépatobiliaire - Hôpital Pitié Salpétrière
Paris, 75013
Adriana TORCIVIA, MD
Adriana TORCIVIA, MD
- Recruiting
AP-HP Hôpîtal Europeen Georges Pompidou
Paris, 75908
Tigran POGHOSYAN, MD
Frank ZINZINDOHOUE, Pr
- Recruiting
Service de Chirurgie Digestive, Générale et Cancérologique - HEGP
Paris, 75908
Tigran POGHOSYAN, MD
Tigran POGHOSYAN, MD
- Recruiting
Service de Chirurgie Générale - Hôpital Privé de la Loire
Saint-Etienne, 42100
Philippe ESPALIEU, MD
Philippe ESPALIEU, MD
- Recruiting
Service de Chirurgie Générale, Digestive et Viscérale - Centre Hospitalier Intercommunal de Poissy / Saint Gerrmain en Laye
Saint-Germain-en-Laye, 78100
Elie CHOUILLARD, MD
Elie CHOUILLARD, MD
- Recruiting
Département de Chirurgie Digestive et Hépatobiliaire - Centre Hospitalier Privé Saint Grégoire
Saint-Grégoire, 35760
Adrien STERKERS, MD
Adrien STERKERS, MD
About this study
Official title: 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)
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.
Read the detailed description
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; indeed, the OAGB remains controversial because considered by many surgeons at risk of biliary reflux and malnutrition.
In France, the national and multicenter randomized trial YOMEGA(NCT02139813), comparing the MGB to the RYGB in a prospective randomized fashion confirmed the non-inferiority of MGB compared to the RYGB in terms of weight loss at 24 months. However, significantly more complications (notably at the nutritional level) were observed in the MGB arm.After the publication of these results in September 2019, the High Authority for health (HAS) in France considered that the MGB 200cm did not constitute a validated technique nor an alternative to the RYGB, due to the worrying safety signals. Reimbursement of the MGB was also put into question by the national insurance health care system.
Nevertheless, the use and advantages of the MGB remain a hot topic with several retrospective data showing that a shorter biliopancreatic loop (150cm) would present a lower nutritional risk and excellent weight and metabolic results. A randomized trial comparing the MGB 150cm to the RYGB will thus begin soon in France (YOMEGA-2). The HAS recommends evaluating its efficacy in terms of long-term weight loss, the resolution of comorbidities but also safety outcomes. Finally, patients who have already been operated by MGB must benefit from follow-up with particular vigilance in the detection of nutritional complications and cancer of the lower esophagus. MGB could also turn out to be less expensive than RYGB: shorter operating time and better control of metabolic diseases The scientific community are still awaiting long-term data to reconsider the place of the MGB in the surgical management of obese patients. The aim of our study is to provide long-term efficacy and safety data on the YOMEGA cohort comparing the MGB to the RYGB, at 5 and 7 years of follow-up.
- Conditions
- Obesity
- Being tested
- Laparoscopic Mini-gastric bypass, Laparoscopic Roux-en-Y Gastric ByPass (RYGBP)
- Keywords
- bariatric surgery, Randomized trial, Roux-en-Y gastric Bypass, One Anastomosis gastric Bypass, long-term results
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Mini-gastric bypassProcedure or surgery
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
Laparoscopic Roux-en-Y Gastric ByPass (RYGBP)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Laparoscopic Mini-gastric bypass | |
| 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. Receives: Procedure: Laparoscopic Roux-en-Y Gastric ByPass (RYGBP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 and 7 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Apr 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549271
- Sponsor's protocol ID
- 773
- Acronym
- YOMEGA 5-7y
- Status last verified
- Sep 2022
- First submitted
- 19 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38452784
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05549271
- Acronym / sponsor ID
- YOMEGA 5-7y / 773
- Conditions
- Obesity
- Keywords
- bariatric surgery, Randomized trial, Roux-en-Y gastric Bypass, One Anastomosis gastric Bypass, long-term results
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 22 Sep 2022 (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.
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.
Detailed description
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; indeed, the OAGB remains controversial because considered by many surgeons at risk of biliary reflux and malnutrition.
In France, the national and multicenter randomized trial YOMEGA(NCT02139813), comparing the MGB to the RYGB in a prospective randomized fashion confirmed the non-inferiority of MGB compared to the RYGB in terms of weight loss at 24 months. However, significantly more complications (notably at the nutritional level) were observed in the MGB arm.After the publication of these results in September 2019, the High Authority for health (HAS) in France considered that the MGB 200cm did not constitute a validated technique nor an alternative to the RYGB, due to the worrying safety signals. Reimbursement of the MGB was also put into question by the national insurance health care system.
Nevertheless, the use and advantages of the MGB remain a hot topic with several retrospective data showing that a shorter biliopancreatic loop (150cm) would present a lower nutritional risk and excellent weight and metabolic results. A randomized trial comparing the MGB 150cm to the RYGB will thus begin soon in France (YOMEGA-2). The HAS recommends evaluating its efficacy in terms of long-term weight loss, the resolution of comorbidities but also safety outcomes. Finally, patients who have already been operated by MGB must benefit from follow-up with particular vigilance in the detection of nutritional complications and cancer of the lower esophagus. MGB could also turn out to be less expensive than RYGB: shorter operating time and better control of metabolic diseases The scientific community are still awaiting long-term data to reconsider the place of the MGB in the surgical management of obese patients. The aim of our study is to provide long-term efficacy and safety data on the YOMEGA cohort comparing the MGB to the RYGB, at 5 and 7 years of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese patients who underwent a Laparoscopic One Anastomosis Gastric Bypass (OAGB) 5 years ago | – | Procedure: Laparoscopic Mini-gastric bypassPatients (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 | – | Procedure: Laparoscopic Roux-en-Y Gastric ByPass (RYGBP)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included in the YOMEGA study, randomized and operated on with the technique assigned to them (121 RYGB and 127 OLB)
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 Mini-gastric bypassThe 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 | Procedure or surgery | Obese patients who underwent a Laparoscopic One Anastomosis Gastric Bypass (OAGB) 5 years ago |
| Laparoscopic Roux-en-Y Gastric ByPass (RYGBP)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. | Procedure or surgery | Obese patients who underwent a Laparoscopic Roux-en-Y Gastric ByPass (RYGBP) 5 years ago |
Primary outcome
Weight loss assessment
Time frame: 5 and 7 years after surgery
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Derived from this study: PubMed 38452784Robert 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.
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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. This study is not recruiting at the moment.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Hospices Civils de Lyon at 9 sites 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 9 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique DELAUNAY, MD (+33.4.72.11.00.64, Dominique.delaunay@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss assessment (time frame: 5 and 7 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05549271, which also lists 1 linked publication.
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 22 Sep 2022.