Surgical Intervention for Morbidly Obese Adolescents

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

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2018-02-28

Brief Summary

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The purpose is to study whether the positive effects from obesity surgery in adults also can be achieved when adolescent subjects are operated.

Our hypothesis is that the effects concerning weight loss, health improvement and improved quality of life will be as good in adolescents as in adults.

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Detailed Description

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Severe obesity in the adolescence is a major concern since there is a constant rise in prevalence worldwide. There is a need of effective tools to treat those patients since the natural course with conservative treatment is very pessimistic. I. e. most of the subjects having a BMI \>40kg/m2 in the adolescence will remain morbidly obese also in their adult life.

The three largest centres in Sweden treating obese children (Stockholm, Gothenburg and Malmö) will offer patients fulfilling the inclusion criteria to be operated with laparoscopic gastric bypass. If not willing to be operated they could join the study as a control case.

Subjects will be investigated at the baseline concerning physical health status and existence of medical risk factors but also regarding their quality of life, eating habits and physical activity. They will subsequently be follow over a ten year period regarding these variables.

Conditions

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Obesity Diabetes Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgery

Laparoscopic gastric bypass

Group Type EXPERIMENTAL

Surgery

Intervention Type PROCEDURE

Laparoscopic Roux-en-Y gastric bypass

2

Traditional treatment for obesity

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Surgery

Laparoscopic Roux-en-Y gastric bypass

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* BMI \>40 kg/m2 or BMI\>35 with comorbidity
* Pass psychological evaluation
* Puberty status Tanner 4-5
* At least one year with active conservative treatment that failed

Exclusion Criteria

* Lack of compliance
* Specific obesity syndrome as Praeder Willis
* Obesity due to brain injury
* Severe general disease
* Specific genetic defect (MC4R, Leptin deficiency)

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No