Gastric Volumetry by Gastric Tomodensitometry With Gas
Ključne besede
Povzetek
Datumi
Nazadnje preverjeno: | 06/30/2018 |
Prvič predloženo: | 10/09/2013 |
Predviden vpis oddan: | 10/10/2013 |
Prvič objavljeno: | 10/15/2013 |
Zadnja posodobitev oddana: | 05/22/2019 |
Zadnja posodobitev objavljena: | 05/27/2019 |
Dejanski datum začetka študija: | 08/31/2012 |
Predvideni datum primarnega zaključka: | 12/31/2014 |
Predvideni datum zaključka študije: | 12/31/2014 |
Stanje ali bolezen
Intervencija / zdravljenje
Device: Patients with morbid obesity
Faza
Skupine rok
Roka | Intervencija / zdravljenje |
---|---|
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 |
Merila upravičenosti
Starost, primerna za študij | 18 Years Za 18 Years |
Spol, upravičen do študija | All |
Sprejema zdrave prostovoljce | Da |
Merila | 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. |
Izid
Primarni izidni ukrepi
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]
Ukrepi sekundarnega rezultata
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]