Gastric Volumetry by Gastric Tomodensitometry With Gas
Ключови думи
Резюме
Дати
Последна проверка: | 06/30/2018 |
Първо изпратено: | 10/09/2013 |
Очаквано записване подадено: | 10/10/2013 |
Първо публикувано: | 10/15/2013 |
Изпратена последна актуализация: | 05/22/2019 |
Последна актуализация публикувана: | 05/27/2019 |
Действителна начална дата на проучването: | 08/31/2012 |
Приблизителна дата на първично завършване: | 12/31/2014 |
Очаквана дата на завършване на проучването: | 12/31/2014 |
Състояние или заболяване
Интервенция / лечение
Device: Patients with morbid obesity
Фаза
Групи за ръце
Arm | Интервенция / лечение |
---|---|
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 |
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
Полове, допустими за проучване | All |
Приема здрави доброволци | Да |
Критерии | 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. |
Резултат
Първични изходни мерки
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]
Вторични изходни мерки
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]