ObesityYOMEGANCT02139813
Omega Loop Versus Roux-en-Y Gastric Bypass
A study testing Laparoscopic Mini-gastric bypass and Procedure of reference in bariatric surgery in people with Obesity, run by Hospices Civils de Lyon at 9 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Laparoscopic Mini-gastric bypass and Procedure of reference in bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 9 sitesFrance
- Study dates
- May 2014to Mar 2018
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Clinique Universitaire de Chirurgie Digestive et de l'Urgence - CHU de Grenoble
Grenoble, 38043
Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche
Guilherand-Granges, 07500
Service de Chirurgie Générale et Endocrinienne - Hôpital Claude Huriez - CHU de Lille
Lille, 59037
Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, 69437
Service de Chirurgie Digestive et Hépato-Bilio-Pancréatique et Transplantation Hépatique - Hôpital de la Pitié Salpêtrière
Paris, 75013
Service de Chirurgie Digestive, Générale et Cancérologique - Hôpital Européen Georges Pompidou - APHP
Paris, 75908
Service de Chirurgie Générale - Hôpital Privé de la Loire
Saint-Etienne, 42100
Service de Chirurgie Générale, Digestive et Viscérale - Centre Hospitalier Intercommunal de Poissy / Saint Gerrmain en Laye
Saint-Germain-en-Laye, 78100
Service de Chirurgie Digestive et Hépato-Biliaire-Centre Hospitalier Privé Saint Grégoire
Saint-Grégoire, 35768
About this study
Official title: Prospective Multicentric Randomized Trial of Efficiency and Safety of Laparoscopic Omega Loop Bypass Versus Roux-en-Y Gastric Bypass
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.
Read more
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
- Being tested
- Laparoscopic Mini-gastric bypass, Procedure of reference in bariatric surgery
- Keywords
- Obesity -, Bariatric surgery, Gastric bypass
- 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 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
Procedure of reference in bariatric surgeryProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Omega Loop Bypass | Experimental | Laparoscopic Mini-gastric bypass Receives: Procedure: Laparoscopic Mini-gastric bypass |
| Laparoscopic Roux-en-Y Gastric ByPass | Active comparator | Procedure of reference in bariatric surgery Receives: Procedure: Procedure of reference in bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years after surgery
Secondary outcomes (13)
Weight loss according to absolute weight loss (aWL in kg), Excess Weight Loss percentage (EWL%), EBL%
Measured: 1, 3, 6, 12, 18 and 24 months after surgery
Waist size reduction according to absolute waist size (in cm)
Measured: 1, 3, 6, 12, 18 and 24 months after surgery
Medical and surgical complication rates
Medical and surgical complication rates (anastomotic leaks, biliary reflux, bowel obstruction, anastomotic ulcers, anastomotic stenosis, internal hernia, chronic gastritis, esophagitis, iron deficiency anemia …)
Measured: 1, 12 and 24 months after surgery
Type and severity of complications
Type and severity of early and late complications for each procedure, according to the Dindo-Clavien classification
Measured: During the month following surgery (for early complications) and from one month to 24 months postoperatively (for late complications)
Operative time
Operative time (expressed in minutes)
Measured: Recorded on the day of surgery (Day 0)
Mean length of stay
Mean length of stay based on the number of days of hospitalization from surgery (Day of surgery = D0) until the end of hospitalization
Measured: Average period of 5 days from surgery (Day of surgery = D0) until the end of hospitalization, recorded on Visit 4 (Month1 +/- 10 days)
Patient's quality of life
Patient's quality of life score according to the IWQOL questionnaire and the BAROS questionnaire adapted to bariatric surgery
Measured: The day before surgery (D-1) and 6, 12 and 24 months after surgery
Metabolic and lipid profile
Metabolic profile of glucose homeostasis and the lipid profile according to antidiabetic and anitilipidemic treatments, HbA1c level, fasting glycemia, HDL, LDL and TG.
Measured: During the period of inclusion (D-60 to D-2) and at 6, 12 and 24 months after surgery
Dumping syndrome and hypoglycemia symptoms
Dumping syndrome and hypoglycemia symptoms will be assessed using the Sigstad questionnaire
Measured: At 1, 3,6,12,18 and 24 months after surgery
Gastroesophageal reflux
Gastroesophageal reflux assessed by items 5 and 27 of the GIQLI questionnaire
Measured: The day before surgery (Day-1) and 6, 12, and 24 months after surgery
Modifications of the gastric and esophageal mucosa
Histological modifications of the gastric and esophageal mucosa, based on upper GI endoscopy with biopsies
Measured: 2 years after surgery
Frequency of diarrhea
Frequency of diarrhea based on items 7, 30, 31 and 36 of the GIQLI questionnaire
Measured: The day before surgery (day-1) and 6, 12, and 24 months after surgery
Nutritional status
Nutritional status, assessed by PTH, vitamin B1, B9, B12, and D levels before and 12 and 24 months after surgery and assessed by hemoglobin, albumin, prealbumin, ferritin, saturation coefficient, before and 6, 12 and 24 months after surgery .
Measured: During the period of inclusion (D-60 to D-2) and 6, 12, and 24 months after surgery (The 24-hour steatorrhea will be quantified at 6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maud ROBERT, MD, Principal investigator, Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139813
- Sponsor's protocol ID
- 2014.851
- Acronym
- YOMEGA
- Status last verified
- Dec 2025
- First submitted
- 12 May 2014
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30851879Robert 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 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentric Randomized Trial of Efficiency and Safety of Laparoscopic Omega Loop Bypass Versus Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT02139813
- Acronym / sponsor ID
- YOMEGA / 2014.851
- Conditions
- Obesity
- Keywords
- Obesity -, Bariatric surgery, Gastric bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 15 May 2014 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Omega Loop Bypass | Experimental | Procedure: Laparoscopic Mini-gastric bypassLaparoscopic Mini-gastric bypass |
| Laparoscopic Roux-en-Y Gastric ByPass | Active comparator | Procedure: Procedure of reference in bariatric surgeryProcedure of reference in bariatric surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 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 | Procedure or surgery | Laparoscopic Omega Loop Bypass |
| Procedure of reference in bariatric surgeryThe 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 | Procedure or surgery | Laparoscopic Roux-en-Y Gastric ByPass |
Primary outcome
Weight loss assessment according to Excess BMI Loss percentage (EBL%)
Time frame: 2 years after surgery
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
13 secondary outcomes
Weight loss according to absolute weight loss (aWL in kg), Excess Weight Loss percentage (EWL%), EBL%
Time frame: 1, 3, 6, 12, 18 and 24 months after surgery
Waist size reduction according to absolute waist size (in cm)
Time frame: 1, 3, 6, 12, 18 and 24 months after surgery
Medical and surgical complication rates
Time frame: 1, 12 and 24 months after surgery
Type and severity of complications
Time frame: During the month following surgery (for early complications) and from one month to 24 months postoperatively (for late complications)
Operative time
Time frame: Recorded on the day of surgery (Day 0)
Mean length of stay
Time frame: Average period of 5 days from surgery (Day of surgery = D0) until the end of hospitalization, recorded on Visit 4 (Month1 +/- 10 days)
Patient's quality of life
Time frame: The day before surgery (D-1) and 6, 12 and 24 months after surgery
Metabolic and lipid profile
Time frame: During the period of inclusion (D-60 to D-2) and at 6, 12 and 24 months after surgery
Dumping syndrome and hypoglycemia symptoms
Time frame: At 1, 3,6,12,18 and 24 months after surgery
Gastroesophageal reflux
Time frame: The day before surgery (Day-1) and 6, 12, and 24 months after surgery
Modifications of the gastric and esophageal mucosa
Time frame: 2 years after surgery
Frequency of diarrhea
Time frame: The day before surgery (day-1) and 6, 12, and 24 months after surgery
Nutritional status
Time frame: During the period of inclusion (D-60 to D-2) and 6, 12, and 24 months after surgery (The 24-hour steatorrhea will be quantified at 6 months).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 30851879Robert 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.
- 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.
Maud ROBERT, MD principal investigator
Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon - France
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Mini-gastric bypass and Procedure of reference in bariatric surgery in people with 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 7 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: finished, as of the sponsor's last update on 19 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss assessment according to Excess BMI Loss percentage (EBL%) (time frame: 2 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 NCT02139813, which also lists 2 linked publications.
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 19 Dec 2025.