Bariatric surgery versus conservative treatment in morbidly obese children

Paediatric obesity is a major problem in the developed world and is the most
common disease in children. Obesity is associated with a higher mortality and
by serious co-morbidity including type-2 diabetes, dyslipidemia, hypertension,
cardiovascular disease, and non-alcoholic steatohepatitis. Obesity is also
associated with an impaired quality of life compared to healthy individuals. In
children and adolescents the effect of diets and medication is small. Bariatric
surgery is the most effective mode of treatment of adult morbid obese patients
and has shown similar weight reduction in adolescents.

To assess the short term and medium term weight loss after bariatric surgery
compared to conservative therapy, to determine the prevalence and the effect of
weight loss on obesity associated morbidity in adolescence, to measure the
effect of bariatric surgery and weight loss on the quality of life and to
estimate the effect of continuous food restriction as result of bariatric
surgery on eating behaviour and responsiveness towards food.

Prospective randomised trial

Laparoscopic Adjustable Gastric Banding

Surgery of morbid obesity is an accepted method to reduce weight and is also
used in adolescents. The patients in the surgery group have a very small risk
of death from the operation (until now world wide 0.0%) The chance of
complications is 5-10%, which includes wound infection and a slipped gastric
band. The latter has to be repositioned with a laparoscopic operation. The
expected benefit of the intervention group is large: reduced excess mortality,
substantial weight loss, reduction of co-morbidity and an important improvement
of the quality of life, with better socio-economic prospects.
The patients in the control group will not benefit directly from the study.
They will be offered surgery as soon as the study has proven that reduction of
obesity associated morbidity and improved quality of life justify the risk of
an operation in adolescents.
The risks and burden of the associated investigations is low.
At assessment the patients get a peripheral venous line to collect 50mL of
blood and to collect blood at the oral glucose tolerance test.(part of standard
treatment) Ultrasonography of the carotid artery, quality of life and behaviour
tests carry no risks and minimal burden to the patients. DXA .
Dopplerultrasonography of the brachial artery and videomicroscopy with 4
minutes ischaemia of the fore arm (done simultaneously) include a short period
of discomfort without any risk to the patient. Laser doppler vasomotion is no
burden for the patient.
After one year, blood sampling, body composition, the quality of life test and
behaviour tests are repeated.
At 3 year the investigations are the same as at initial assessment.