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Surgical Intervention for Morbidly Obese Adolescents

Surgical Intervention With Laparoscopic Roux-en-Y Gastric Bypass for Morbid Obesity in Adolescence - a Matched Control Study

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00289705
Enrollment
80
Registered
2006-02-10
Start date
2006-02-28
Completion date
2018-02-28
Last updated
2017-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hypertension, Obesity

Keywords

Obesity, Surgery, Adolescent, Roux-en-Y gastric bypass, Laparoscopic

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURESurgery

Laparoscopic Roux-en-Y gastric bypass

Sponsors

Göteborg University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
BMI development10 years

Secondary

MeasureTime frame
Medical risk factors, incidence of diseases (such as diabetes, hypertension etc), quality of life, socioeconomic development, eating pattern.10 years

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026