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Official title Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
ClinicalTrials.gov ID: NCT04994665
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Multidisciplinary follow-up of at least 6 months before surgery
- Validation of the surgical intervention in a multidisciplinary consultation meeting
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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.
- 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
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Bayonne, France
- La Roche-sur-Yon, France
- Le Puy-en-Velay, France
- Nantes, France
- Orléans, France
- Rennes, France
- Saint-Herblain, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bayonne, France; La Roche-sur-Yon, France; Le Puy-en-Velay, France; Nantes, France; Orléans, France; Rennes, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.