Status:
UNKNOWN
Bariatric Surgery in Children.
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Obesity, Morbid
Eligibility:
All Genders
14-16 years
Phase:
NA
Brief Summary
Rationale: In the Western world overweight and obesity is an increasing problem both in adults and in children. In youth, it is associated with early death and a number of co-morbidities including me...
Eligibility Criteria
Inclusion
- Aged 14 to 16
- Age and sex adjusted BMI \>40 kg/m2 or \>35 kg/m2 with associated co-morbidity.
- \* Associated co-morbidity includes: glucose intolerance, type 2 diabetes, hypertension, pseudotumor cerebri, acanthosis nigricans, obstructive sleep apnoea syndrome, depression, arthropathies, non-alcoholic steatohepatitis and dyslipidemia.
- \> 1 year multidisciplinary organized weight reducing attempts with less than 5% weight loss
- Demonstrate decisional capacity
Exclusion
- Psychologically not suitable
- Pre-menarche or bone age \<15 years in boys
- Obesity associated to other disorders such as hypothyroidism
- Syndromal disorders such as Prader-Willi syndrome
- Severe cardiorespiratory impairment (ASA class 3 or higher)
- Insufficiently fluid in the Dutch language
- Unwillingness to adhere to follow-up programmes
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01172899
Start Date
December 1 2011
End Date
December 1 2022
Last Update
August 26 2021
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6202ZA