Bariatric Surgery in Children.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-01

Study Completion Date

2022-12-31

Brief Summary

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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 metabolic and endocrine changes, increased inflammatory status, cardiovascular abnormalities, nonalcoholic fatty liver disease, and impaired quality of life.

The standard treatment for morbid obesity in children is by combined life style interventions. However, the medium and long term effects of dietetic interventions, behaviour therapy and medication is relatively poor. In adults bariatric surgery shows good results with up to 30% weight reduction in 3 years. The preliminary results in youth are similar, but surgery in this age group is relatively uncommon. In the Netherlands surgery in this age group is only allowed in clinical trials, until the benefits and risks have been established. (National Health Authorities)

Objective:

To determine if surgery gives a superior weight and body mass index (BMI) reduction than combined life style interventions in adolescents with morbid obesity and to assess its effect on obesity associated co-morbidity.

Study design:

Prospective randomised interventional study.

Study population:

Morbidly obese children, aged 14 - 16 years, with sex and age adjusted BMI \>40 kg/m2 or \>35 kg/m2 with co-morbidity.

Intervention:

Bariatric surgery by laparoscopic adjustable gastric band (LAGB) or combined life style interventions

Main study parameters/endpoints:

Primary endpoints: weight loss, loss of excess weight, loss of excess BMI. Secondary endpoints: Body composition, pubertal development, metabolic and endocrine changes, inflammatory status, cardiovascular abnormalities, non-alcoholic steatohepatitis, brain development, quality of life, and behaviour changes. The potential complications of surgery are monitored.

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Detailed Description

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Conditions

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Obesity, Morbid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Laparoscopic adjustable gastric band

Group Type EXPERIMENTAL

laparoscopic adjustable gastric band

Intervention Type PROCEDURE

Laparoscopic gastric band placement. Combined lifestyle interventions will continue after surgery.

Combined life style interventions

Intervention Type BEHAVIORAL

Control group will receive standard therapy consisting of combined lifestyle interventions.

Control group

Group Type ACTIVE_COMPARATOR

Combined life style interventions

Intervention Type BEHAVIORAL

Control group will receive standard therapy consisting of combined lifestyle interventions.

Interventions

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laparoscopic adjustable gastric band

Laparoscopic gastric band placement. Combined lifestyle interventions will continue after surgery.

Intervention Type PROCEDURE

Combined life style interventions

Control group will receive standard therapy consisting of combined lifestyle interventions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

14 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No