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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleeve gastrectomy | Active Comparator | realization of a sleeve gastrectomy alone |
|
| sleeve gastrectomy with omentopexy | Experimental | realization of a sleeve gastrectomy followed by an omentopexy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sleeve gastrectomy | Procedure | The sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years postoperatively |
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Inclusion Criteria:
OR initial BMI ≥ 40 Kg/m².
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agnès Dorion | Contact | 251446380 | +33 | agnes.dorion@chd-vendee.fr |
| Name | Affiliation | Role |
|---|---|---|
| Emeric Abet, Dr | CHD Vendée | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH de la Cote Basque | Recruiting | Bayonne | France |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| sleeve gastrectomy with omentopexy | Procedure | 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 |
|
| CHD Vendée | Recruiting | La Roche-sur-Yon | 85000 | France |
|
| Centre Hospitalier Emile Roux | Recruiting | Le Puy-en-Velay | 43012 | France |
|
| CHU Nantes | Recruiting | Nantes | 44000 | France |
|
| Clinique Jules Verne | Recruiting | Nantes | 44300 | France |
|
| Centre Hospitalier Régional et Universitaire d'Orléans | Recruiting | Orléans | France |
|
| Hopital Pontchaillou | Recruiting | Rennes | 35000 | France |
|
| Clinique Mutualiste de la Sagesse | Not yet recruiting | Rennes | France |
|
| Clinique Santé Atlantique | Recruiting | Saint-Herblain | 44800 | France |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |