Comparison of the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventi… (NCT04626232) | Clinical Trial Compass
TerminatedNot Applicable
Comparison of the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique in Morbidly Obese Patients
Stopped: no inclusions
France2 participantsStarted 2022-09-12
Plain-language summary
The purpose of this study is to evaluate the impact of the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve) vs conventional sleeve gastrectomy technique
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Signed informed consent form
* Subjects must be able to attend all scheduled visits and to comply with all trial procedures
* Subjects must be covered by public health insurance
* Contraception efficacy
* Subjects eligible for sleeve gastrectomy after multidisciplinary evaluation according to HAS 2009 criteria: BMI ≥ 40 kg / m² with failure of the dietary treatment for at least 1 year, or a BMI ≥ 35kg / m² with at least one co-morbidity that could be improved after surgery (hypertension, obstructive sleep apnea hypopnea syndrome (OSAHS) and other severe respiratory disorders, severe metabolic disorders (especially type 2 diabetes), debilitating musculoskeletal diseases, non-alcoholic steato-hepatitis (NASH))
Exclusion Criteria:
* Subject unable to read or/and write
* Planned longer stay outside the region that prevents compliance with the visit plan
* Current pregnancy
* Previous bariatric surgery (ring, vertical banded gastroplasty, sleeve gastrectomy or Gastric Bypass).
* BMI \> 50 kg / m² for women and \> 45kg / m² for men (dissecting the hiatus region can be a technical challenge in these cases).
* Barrett oesophagus and esophagitis stage III and IV.
* Funditis
* Long-term NSAIDs and/or corticosteroid therapy
* No affiliation at the French social security scheme.
* Major protected by law.
* Deprivation of liberty by judicial or administrative decision.
* Participation to another clinical research program.