5 and 7-year Follow-up of the YOMEGA Trial Cohort (YOMEGA 5-7y)

September 19, 2022 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
248

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Guilherand-Granges, France, 07500
        • Recruiting
        • Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche
        • Contact:
          • Vincent MALHERBE, MD
        • Principal Investigator:
          • Vincent MALHERBE, MD
      • Lille, France, 59037
        • Recruiting
        • Service de Chirurgie Générale et Endocrinienne - Hôpital Claude Huriez - CHU de Lille
        • Contact:
          • François PATTOU, MD
        • Principal Investigator:
          • François PATTOU, MD
      • Lyon, France
        • Recruiting
        • Service de Chirurgie Digestive Hôpital Edouard Herriot
        • Contact:
      • Paris, France, 75013
        • Recruiting
        • Département de Chirurgie Digestive et Hépatobiliaire - Hôpital Pitié Salpétrière
        • Contact:
          • Adriana TORCIVIA, MD
        • Principal Investigator:
          • Adriana TORCIVIA, MD
      • Paris, France, 75908
        • Recruiting
        • Service de Chirurgie Digestive, Générale et Cancérologique - HEGP
        • Contact:
          • Tigran POGHOSYAN, MD
        • Principal Investigator:
          • Tigran POGHOSYAN, MD
      • Paris Cedex 15, France, 75908
        • Recruiting
        • AP-HP Hopital Europeen Georges Pompidou
        • Contact:
          • Tigran POGHOSYAN, MD
        • Principal Investigator:
          • Frank ZINZINDOHOUE, Pr
      • Saint Etienne, France, 42100
        • Recruiting
        • Service de Chirurgie Générale - Hôpital Privé de la Loire
        • Contact:
          • Philippe ESPALIEU, MD
        • Principal Investigator:
          • Philippe ESPALIEU, MD
        • Sub-Investigator:
          • Marc CHABERT, MD
      • Saint-Grégoire, France, 35760
        • Recruiting
        • Département de Chirurgie Digestive et Hépatobiliaire - Centre Hospitalier Privé Saint Grégoire
        • Contact:
          • Adrien STERKERS, MD
        • Principal Investigator:
          • Adrien STERKERS, MD
      • Saint-germain-en-laye, France, 78100
        • Recruiting
        • Service de Chirurgie Générale, Digestive et Viscérale - Centre Hospitalier Intercommunal de Poissy / Saint Gerrmain en Laye
        • Contact:
          • Elie CHOUILLARD, MD
        • Principal Investigator:
          • Elie CHOUILLARD, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients included in the YOMEGA study, randomized and operated on with the technique assigned to them (121 RYGB and 127 OLB)

Description

Inclusion Criteria:

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
  • 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

Exclusion Criteria:

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Procedure: Laparoscopic Mini-gastric bypass
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
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
5 and 7 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 773

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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