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Активно (без набиране) Не е приложимо NCT00923819

4XL Study - Obesity Surgery in Adolescence

Не е приложима фаза (напр. обсервационно)
Заболявания: Obesity, Morbid

Спонсор: Sykehuset i Vestfold HF

Налично на: БГ
Обобщение
The purpose of this study on adolescents between 13 and 18 years of age with morbid obesity is to determine whether surgical treatment gives more health benefits than standard conservative treatment, and if laparoscopic gastric bypass is a method with high safety and a low complication rate.
Описание
The study has two intervention arms: Experimental: Group A Surgery; laparoscopic gastric bypass Active comparator: Group B Patients from Child Obesity Registry of Vestfold who get standard conservative treatment in a multidisiplinary team at Morbid Obesity Center. All patients are referred to Morbid Obesity Center from other hospitals or general practionairs in Norway. The procedure will take place at the Vestfold Hospital Trust The participants are included for 2 years follow-up with visits to a multidisciplinary team every 3rd month at the Morbid Obesity Center. Total follow-up time is ten years.
Кой може да участва
Inclusion Criteria: * Between 13 and 18 years of age at inclusion * Tanner stage 4-5 * BMI \> 40 kg/m2 or BMI \> 35 with at least one comorbidity (type 2-diabetes, obstructive sleep apnea, serious hypertension or cerebral pseudotumor) * At least one year multidisciplinary treatment completed Exclusion Criteria: * Tanner stage \< 4 * Substantial risk for lack of compliance * Obesity syndrome (e.g., Prader Willi syndrome) * Obesity related to brain damage * Serious general disease * Monogenic obesity
Интервенции
Laparoscopic gastric bypass
PROCEDURE
Standard conservative treatment
BEHAVIORAL
Места на провеждане 1
Норвегия (1)
Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority
Tønsberg
Технически детайли
Статус
Активно (без набиране)
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
13 Years
Максимална възраст
18 Years
Здрави доброволци
Не
Начална дата
01.06.2009
Крайна дата
01.12.2035
Регистрационен номер
NCT00923819
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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