Status:
TERMINATED
Randomised Trial of Intensive Behavioral Lifestyle Intervention Versus Usual Preparation for Bariatric Surgery
Lead Sponsor:
IHU Strasbourg
Conditions:
Morbid Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Prospective randomized clinical trial aiming to compare a comprehensive, intensive behavioral lifestyle intervention and usual care during the preoperative preparation to bariatric surgery, with prima...
Detailed Description
Obesity is a complex, multifactorial pathology that has major public health importance. Lifestyle modification is the cornerstone of all obesity treatments, including surgery. Throughout the non-surgi...
Eligibility Criteria
Inclusion
- Patient with a BMI (Body Mass Index) of 40 or BMI of 35 with associated comorbidity and who desires obesity surgery
- Patient agreeing to participate in the study, including the 2 years follow-up
- Patient accepting the constraints of the study related to the group to which he/she will be assigned as a result of randomization (availability to his work, his family, etc.)
- Patient able to receive and to understand the study information and to give written informed consent
- Patient affiliated with the French social security system
Exclusion
- Patient with a BMI of more than 60
- Patient with contraindication to laparoscopic obesity surgery
- Patient already operated on for obesity
- Patient with a history of major abdominal surgery
- Patient with contraindications to MRI:
- pace maker or automatic defibrillator, implanted insulin pump
- auditory neurostimulator, anal neurostimulator, etc.
- ferromagnetic bodies in soft tissues, intraocular foreign bodies, cerebral vascular clips
- claustrophobia
- morphotype not allowing access to MRI: morbid obesity with waist circumference greater than 150 cm, shoulder width greater than 59 cm
- Patient with psychiatric pathology (untreated psychosis, drug dependence, etc.)
- Pregnant or breast-feeding patient
- Patient in periods of exclusion (determined by a previous or ongoing study)
- Patient under safeguard of justice
- Patient under guardianship
Key Trial Info
Start Date :
September 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2025
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04282304
Start Date
September 11 2020
End Date
April 4 2025
Last Update
May 1 2025
Active Locations (1)
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1
Service de Chirurgie Digestive et Endocrinienne, NHC
Strasbourg, France, 67000