Gastric Volumetry by Gastric Tomodensitometry With Gas
Raktažodžiai
Santrauka
Datos
Paskutinį kartą patikrinta: | 06/30/2018 |
Pirmasis pateikimas: | 10/09/2013 |
Numatytas registravimas pateiktas: | 10/10/2013 |
Pirmas paskelbtas: | 10/15/2013 |
Paskutinis atnaujinimas pateiktas: | 05/22/2019 |
Paskutinis atnaujinimas paskelbtas: | 05/27/2019 |
Faktinė studijų pradžios data: | 08/31/2012 |
Numatoma pirminio užbaigimo data: | 12/31/2014 |
Numatoma studijų užbaigimo data: | 12/31/2014 |
Būklė ar liga
Intervencija / gydymas
Device: Patients with morbid obesity
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
Experimental: Patients with morbid obesity Patients with morbid obesity and who requires a gastric bypass or a Sleeve gastrectomy as a 1st bariatric procedure. | Device: Patients with morbid obesity |
Tinkamumo kriterijai
Amžius, tinkami studijuoti | 18 Years Į 18 Years |
Tinkamos studijoms lytys | All |
Priima sveikus savanorius | Taip |
Kriterijai | Inclusion Criteria: - Patients of both genders, with morbid obesity (BMI > or = 40kg / m ²) - Age included between 18 and 60 years - Patient who requires a gastric bypass or a Sleeve gastrectomy as a 1st bariatric procedure. Indication validated in pluridisciplinary concertation meeting for bariatric surgery - No previous history of bariatric surgery - Free and informed consent signed - Being affiliated to a French social security system or similar. Exclusion Criteria: - Bariatric surgery with metabolic aim (BMI < 40kg / m ²) - Patients with a history of bariatric surgery, after failure of one or several previous procedures - Contraindication to radiation exposition: current or planned pregnancy during the study - prostate adenoma : contraindication to antispasmodic - Known allergy to effervescent salts or butylscopolamine (Scoburen) - Glaucoma - Inability to express a consent - Unaffiliated patients to a French national insurance - Patients with Pacemaker - Patients already enrolled in a study with a conflict of interest with this study. |
Rezultatas
Pirminės rezultatų priemonės
1. the neostomach volume measured by gastrictomodensitometry with gas [3 and 12 month]
2. the subjects' weight at the 3rd and the 12th month after GBP or SG [3 and 12 months]
Antrinės rezultatų priemonės
1. the neostomach volume at 12 months and total weightloss [12 month]
2. determination of the positive predictive value of the neostomach volume at 3 months, on weight evolution at 12 months after GBP or SG [3 and 12 month]
3. the volume of the neostomach at 3 and 12 months between the subjects who gain weight and thosewho do not [3 and 12 month]
4. standard values for gastricvolumetry by gastrictomodensitometry with gas, at 3 and 12 months after GBP or SG [3 and 12 month]