Bypass ComplicationOMEGA10NCT04930029
Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega
An observational study of Bypass Complication and Obesity, run by University Hospital, Lille at 1 site in France.
Trial summary
The omega gastric bypass (OAGB) is developing worldwide as an alternative to the Y gastric bypass (RYGB). Cases of nutrition deficiency after OAGB, in particular protein deficency, are regularly reported in the literature, raising the question of the medium/long-term safety of this procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bypass Complication, Obesity
- What is being tested?
- Ten year evaluation
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2021to Jul 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study involves patients: * operated between 2008 and 2013 for an OAGB with a 150 or 200cm biliary limb * fulfilling the HAS criteria(HAS, 2009) at the time of their surgery: BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with a comorbidity likely to be improved by weight loss * benefiting from a follow-up.
Who may be able to join
- Patients who received 10 ± 2 years ago (between 2009 and 2013) an OAGB with a 150 or 200cm biliary limb. Patients should be consecutive at each center.
- Patients fulfilling the criteria of indication for bariatric surgery at the time of their intervention according to the recommendations of the HAS (HAS, 2009) in an expert center.
- Patients agreeing to perform an endoscopic evaluation with biopsies at 10 years
- Patients who gave their consent
- Patients with health insurance coverage
Who cannot join
- Contraindication to bariatric surgery defined according to HAS recommendations (HAS, 2009)
- Persons deprived of liberty, under guardianship, or under curatorship
- Patients included in a protocol with a conflict of interest with OMEGA10.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Claude Huriez - Service de chirurgie générale et endocrinienne
Lille
Robert Caiazzo, 03 20 44 42 73, robert.caiazzo@chru-lille.fr
About this study
The omega gastric bypass (OAGB) is developing worldwide as an alternative to the Y gastric bypass (RYGB). Cases of nutrition deficiency after OAGB, in particular protein deficency, are regularly reported in the literature, raising the question of the medium/long-term safety of this procedure. In its technology assessment report issued in September 2019 (HAS, 2019), the Haute Autorité de Santé rules on the invalidity of OAGB with a 200 cm biliary limb and the lack of sufficient data on the safety of OAGB with a 150 cm biliary limb compared to RYGB. The lack of long-term data on weight, resolution of comorbidities, quality of life, and endoscopic evaluation given the risk of lower esophageal cancer is also noted.
The main objective of the study is to compare the incidence of serious adverse events related to surgery after OAGB at 10 years, according to 2 types of loop: a realization with a 150-cm biliary loop (OAGB AB150) versus a realization with a 200-cm biliary loop (OAGB AB200).
- Conditions
- Bypass Complication, Obesity
- Being tested
- Ten year evaluation
- Keywords
- One anastomosis gastric bypass, obesity, bariatric surgery, GERD, long term
- Medical subject headings
- Obesity, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ten year evaluationOther
Clinical, biological and endoscopic evaluation
| Study group | Role | What they receive |
|---|---|---|
| OAGB150 | One anastomosis gastric bypass with 150cm biliary limb Receives: Other: Ten year evaluation | |
| OAGB200 | One anastomosis gastric bypass with 200cm biliary limb Receives: Other: Ten year evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious surgery-related adverse events
A serious adverse event is defined as a medical event that requires hospitalization, is life-threatening, results in persistent or substantial disability, or results in death. The "surgery-related" character will be described by each investigator in the first instance and homogenized by the group of experts designated at the beginning of the study.
Measured: 10 years after surgery
Secondary outcomes (12)
incidence of serious adverse events not related to surgery
Measured: 10 years after surgery
Nutritional biological status , assessed by evaluation of malnutrition parameters
Measured: 10 years after surgery
Nutritional clinical status, assessed by dietitian evaluation
Measured: 10 years after surgery
Excess weight loss percentage
calculated as follows: (weight at 10 years - initial weight) / (initial weight - ideal weight) x 100 The ideal weight is defined as the weight corresponding to a BMI = 25 kg/m2. The initial weight is the weight on the day of surgery.
Measured: 10 years after surgery
Metabolic comorbidities remission
Measured: 10 years after surgery
Diabetes remission
Measured: 10 years after surgery
Hypertension remission
Measured: 10 years after surgery
Obstructive sleep apnea remission
Measured: 10 years after surgery
Dyslipidemia remission
Measured: 10 years after surgery
Quality of life by BAROS score (Bariatric analysis and reporting outcome system)
Measured: 10 years after surgery
Quality of life by GIQLI score (Gastro Intestinal Quality of Life index) questionnaires
The GIQLI is a score to evaluate digestive disorders in 36 items, ranging from 0 (the worst quality of life) to 144 (the best quality of life).
Measured: 10 years after surgery
GERD
GERD, assessed by clinical evaluation, PPI use, and endoscopic signs of GERD (gastritis, oesophagitis, anastomotic ulcer, Barrett's esophagus, gastric metaplasia, esophageal metaplasia
Measured: 10 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 posted18 Jun 2021
- Study start15 Sep 2021
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bypass ComplicationStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert CAIAZZO, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930029
- Sponsor's protocol ID
- 2020_82
- Other IDs
- 2020-A03156-33
- Acronym
- OMEGA10
- Status last verified
- Dec 2025
- First submitted
- 10 Jun 2021
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega
- ClinicalTrials.gov ID
- NCT04930029
- Acronym / sponsor ID
- OMEGA10 / 2020_82
- Conditions
- Bypass Complication, Obesity
- Keywords
- One anastomosis gastric bypass, obesity, bariatric surgery, GERD, long term
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 18 Jun 2021 (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.
The omega gastric bypass (OAGB) is developing worldwide as an alternative to the Y gastric bypass (RYGB). Cases of nutrition deficiency after OAGB, in particular protein deficency, are regularly reported in the literature, raising the question of the medium/long-term safety of this procedure. In its technology assessment report issued in September 2019 (HAS, 2019), the Haute Autorité de Santé rules on the invalidity of OAGB with a 200 cm biliary limb and the lack of sufficient data on the safety of OAGB with a 150 cm biliary limb compared to RYGB. The lack of long-term data on weight, resolution of comorbidities, quality of life, and endoscopic evaluation given the risk of lower esophageal cancer is also noted.
The main objective of the study is to compare the incidence of serious adverse events related to surgery after OAGB at 10 years, according to 2 types of loop: a realization with a 150-cm biliary loop (OAGB AB150) versus a realization with a 200-cm biliary loop (OAGB AB200).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OAGB150 | – | Other: Ten year evaluationOne anastomosis gastric bypass with 150cm biliary limb |
| OAGB200 | – | Other: Ten year evaluationOne anastomosis gastric bypass with 200cm biliary limb |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study involves patients: * operated between 2008 and 2013 for an OAGB with a 150 or 200cm biliary limb * fulfilling the HAS criteria(HAS, 2009) at the time of their surgery: BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with a comorbidity likely to be improved by weight loss * benefiting from a follow-up.
Key inclusion criteria (5 listed)
- Patients who received 10 ± 2 years ago (between 2009 and 2013) an OAGB with a 150 or 200cm biliary limb. Patients should be consecutive at each center.
- Patients fulfilling the criteria of indication for bariatric surgery at the time of their intervention according to the recommendations of the HAS (HAS, 2009) in an expert center.
- Patients agreeing to perform an endoscopic evaluation with biopsies at 10 years
- Patients who gave their consent
- Patients with health insurance coverage
Key exclusion criteria (3 listed)
- Contraindication to bariatric surgery defined according to HAS recommendations (HAS, 2009)
- Persons deprived of liberty, under guardianship, or under curatorship
- Patients included in a protocol with a conflict of interest with OMEGA10.
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 |
|---|---|---|
| Ten year evaluationClinical, biological and endoscopic evaluation | Other | OAGB150, OAGB200 |
Primary outcome
Incidence of serious surgery-related adverse events
Time frame: 10 years after surgery
A serious adverse event is defined as a medical event that requires hospitalization, is life-threatening, results in persistent or substantial disability, or results in death. The "surgery-related" character will be described by each investigator in the first instance and homogenized by the group of experts designated at the beginning of the study.
12 secondary outcomes
incidence of serious adverse events not related to surgery
Time frame: 10 years after surgery
Nutritional biological status , assessed by evaluation of malnutrition parameters
Time frame: 10 years after surgery
Nutritional clinical status, assessed by dietitian evaluation
Time frame: 10 years after surgery
Excess weight loss percentage
Time frame: 10 years after surgery
Metabolic comorbidities remission
Time frame: 10 years after surgery
Diabetes remission
Time frame: 10 years after surgery
Hypertension remission
Time frame: 10 years after surgery
Obstructive sleep apnea remission
Time frame: 10 years after surgery
Dyslipidemia remission
Time frame: 10 years after surgery
Quality of life by BAROS score (Bariatric analysis and reporting outcome system)
Time frame: 10 years after surgery
Quality of life by GIQLI score (Gastro Intestinal Quality of Life index) questionnaires
Time frame: 10 years after surgery
GERD
Time frame: 10 years 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 26 Dec 2025.
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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.
Robert CAIAZZO, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bypass Complication and Obesity, run by University Hospital, Lille 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 5 inclusion and 3 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 26 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 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 Robert CAIAZZO, MD,PhD (0320445962 ext. +33, robert.caiazzo@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious surgery-related adverse events (time frame: 10 years after surgery). 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 26 Dec 2025.