ObesitySleevepexieNCT04994665
Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
A study testing sleeve gastrectomy and sleeve gastrectomy with omentopexy in people with Obesity, run by Centre Hospitalier Departemental Vendee at 9 sites in France.
Trial summary
The aim of the study is to assess impact of omentopexy on de novo gastro-oesophageal reflux disease (GERD) after sleeve gastrectomy. This will be assess 2 years postoperatively. This study is a prospective, multicentric, randomized trial. Five hundred twenty six patients should be included with 263 in each arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- sleeve gastrectomy and sleeve gastrectomy with omentopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 526 participants
- Where
- 9 sitesFrance
- Study dates
- 7 Dec 2021to 1 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥ 18 years old,
- Patient to be operated in first intention of a sleeve gastrectomy
- Initial BMI between 35Kg/m² and 40 Kg/m² associated with at least one severe comorbidity likely to be improved after surgery according to HAS recommendations.
- OR initial BMI ≥ 40 Kg/m².
- Multidisciplinary follow-up of at least 6 months before surgery
- Validation of the surgical intervention in a multidisciplinary consultation meeting
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- Certificate of no contraindication by a psychiatrist
- Patient who has the capacity to understand the protocol and has given consent to participate in the research,
- Patient with social security coverage.
Who cannot join
- Eating disorder or mental disorder
- Misunderstanding of the protocol
- Psychiatric contraindication
- Initial BMI <35Kg/m².
- Initial BMI between 35Kg/m² and 40 Kg/m² without comorbidities.
- Esophagitis of grade B and above on the Oeso-Gastro-Duodenal Fibroscopy
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- CARLSSON score (score ≥ 4) preoperatively
- Presence of a Proton-Pump Inhibitors treatment
- Patient to have a 2-stage surgery (first sleeve gastrectomy then gastric bypass or Single Anastomosis Duodeno-Ileal bypass)
- Patient participating in another interventional clinical research protocol involving a drug or medical device
- Patient who are pregnant, breastfeeding, or who have the potential to become pregnant without effective contraception at the time of inclusion and up to 24 months after surgery
- Patient under guardianship, curators or legal protection,P
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
CH de la Cote Basque
Bayonne
Renaud GONTIER, Dr
- Recruiting
CHD Vendée
La Roche-sur-Yon, 85000
Emeric ABET, Dr
- Recruiting
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43012
Luis Matias BRUNA
- Recruiting
CHU Nantes
Nantes, 44000
Claire BLANCHARD, Dr
- Recruiting
Clinique Jules Verne
Nantes, 44300
Laurent POTIRON
- Recruiting
Centre Hospitalier Régional et Universitaire d'Orléans
Orléans
Adel ABOU-MRAD, Dr
- Recruiting
Hopital Pontchaillou
Rennes, 35000
Marie LIVIN, Dr
- Not yet recruiting
Clinique Mutualiste de la Sagesse
Rennes
Damien BERGEAT, Dr
- Recruiting
Clinique Santé Atlantique
Saint-Herblain, 44800
Antoine SINA, Dr
About this study
The aim of the study is to assess impact of omentopexy on de novo gastro-oesophageal reflux disease (GERD) after sleeve gastrectomy.
This will be assess 2 years postoperatively. This study is a prospective, multicentric, randomized trial. Five hundred twenty six patients should be included with 263 in each arm. First arm will include patients who have a sleeve gastrectomy. The second arm will include patients who have sleeve gastrectomy with omentopexy.
Read more
Two years after surgery , it will be collected a CARLSSON score and BAROS score (quality of life).
The main objective is to show that omentopexy decreases the rate of de novo GERD after sleeve gastrectomy at 2 years postoperatively without the use of Proton-Pump Inhibitors (PPIs)
- Conditions
- Obesity
- Being tested
- sleeve gastrectomy, sleeve gastrectomy with omentopexy
- Keywords
- sleeve gastrectomy, omentopexy, gastro-oesophageal disease
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleeve gastrectomyProcedure or surgery
The sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed
sleeve gastrectomy with omentopexyProcedure or surgery
After sleeve gastrectomy procedure, the omentopexy involves suturing the omentum back to the greater curvature of the stomach in several locations, depending on the length of the greater curvature
| Study group | Role | What they receive |
|---|---|---|
| Sleeve gastrectomy | Active comparator | realization of a sleeve gastrectomy alone Receives: Procedure: sleeve gastrectomy |
| sleeve gastrectomy with omentopexy | Experimental | realization of a sleeve gastrectomy followed by an omentopexy Receives: Procedure: sleeve gastrectomy with omentopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate de novo GERD of patient benefited from sleeve gastrectomy with omentopexy versus sleeve gastrectomy alone
Presence of de novo GERD defined by a clinical score of CARLSSON >= 4 and/or the use of a PPIs treatment
Measured: 2 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start7 Dec 2021
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 526 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emeric Abet, Dr, Principal investigator, CHD Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994665
- Sponsor's protocol ID
- CHD21_0032
- Acronym
- Sleevepexie
- Status last verified
- Sep 2025
- First submitted
- 29 Jul 2021
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT04994665
- Acronym / sponsor ID
- Sleevepexie / CHD21_0032
- Conditions
- Obesity
- Keywords
- sleeve gastrectomy, omentopexy, gastro-oesophageal disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 526 participants (estimated)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 6 Aug 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 aim of the study is to assess impact of omentopexy on de novo gastro-oesophageal reflux disease (GERD) after sleeve gastrectomy.
This will be assess 2 years postoperatively. This study is a prospective, multicentric, randomized trial. Five hundred twenty six patients should be included with 263 in each arm. First arm will include patients who have a sleeve gastrectomy. The second arm will include patients who have sleeve gastrectomy with omentopexy.
Two years after surgery , it will be collected a CARLSSON score and BAROS score (quality of life).
The main objective is to show that omentopexy decreases the rate of de novo GERD after sleeve gastrectomy at 2 years postoperatively without the use of Proton-Pump Inhibitors (PPIs)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleeve gastrectomy | Active comparator | Procedure: sleeve gastrectomyrealization of a sleeve gastrectomy alone |
| sleeve gastrectomy with omentopexy | Experimental | Procedure: sleeve gastrectomy with omentopexyrealization of a sleeve gastrectomy followed by an omentopexy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient ≥ 18 years old,
- Patient to be operated in first intention of a sleeve gastrectomy
- Initial BMI between 35Kg/m² and 40 Kg/m² associated with at least one severe comorbidity likely to be improved after surgery according to HAS recommendations.
- OR initial BMI ≥ 40 Kg/m².
- Multidisciplinary follow-up of at least 6 months before surgery
Key exclusion criteria (12 listed)
- Eating disorder or mental disorder
- Misunderstanding of the protocol
- Psychiatric contraindication
- Initial BMI <35Kg/m².
- Initial BMI between 35Kg/m² and 40 Kg/m² without comorbidities.
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 |
|---|---|---|
| sleeve gastrectomyThe sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed | Procedure or surgery | Sleeve gastrectomy |
| sleeve gastrectomy with omentopexyAfter sleeve gastrectomy procedure, the omentopexy involves suturing the omentum back to the greater curvature of the stomach in several locations, depending on the length of the greater curvature | Procedure or surgery | sleeve gastrectomy with omentopexy |
Primary outcome
Evaluate de novo GERD of patient benefited from sleeve gastrectomy with omentopexy versus sleeve gastrectomy alone
Time frame: 2 years postoperatively
Presence of de novo GERD defined by a clinical score of CARLSSON >= 4 and/or the use of a PPIs treatment
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 23 Sep 2025.
- 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.
Emeric Abet, Dr principal investigator
CHD Vendée
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleeve gastrectomy and sleeve gastrectomy with omentopexy in people with Obesity, run by Centre Hospitalier Departemental Vendee 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 12 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 23 Sep 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?
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 Agnès Dorion (251446380 ext. +33, agnes.dorion@chd-vendee.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate de novo GERD of patient benefited from sleeve gastrectomy with omentopexy versus sleeve gastrectomy alone (time frame: 2 years postoperatively). 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 23 Sep 2025.