Weight Loss Surgery in Adolescents With Extreme Obesity (YES)

Prof. Dr. Martin Wabitsch

Status: Active, not recruiting

Conditions: Extreme Obesity; Obesity

Treatments: Other: conservative care; Procedure: bariatric surgery

Study type: Observational

Funder types: Other

Identifiers

NCT02062164

U1111-1131-8145 (Other Identifier)

DRKS00004172 (Registry Identifier)

01GI1120A (Other Grant/Funding Number)

U1111-1131-4384c

Details and patient eligibility

About

The use of bariatric surgery in adolescents is controversial. On one side, bariatric surgery is the only effective treatment to achieve sustained weight loss in adults with extreme obesity. Comorbidities are reversed and mortality is reduced. In adolescents, bariatric surgery is equally effective; however, due to the paucity of long-term data, the long-term effects and risks are unknown. Thus, due to surgical risk and ethical implications, bariatric surgery is considered experimental in Germany. Nevertheless, case volumes are increasing.

The aim of this study is to evaluate the benefits and risks of adolescent bariatric surgery in the context of a structured preparation and follow-up program. The study is a subproject of the study "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care" (DRKS00004172). At 5 German university centers (Ulm, Datteln, Berlin, Essen, Leipzig), youth who undergo bariatric surgery and are participants in the overall project will be enrolled in a structured preparation and follow-up program. The program is designed to improve adherence and compliance and will result in comprehensive follow-up data. In addition to the data gathered in the overall project, subjects participating in subproject 3 will undergo assessments pertinent to bariatric surgery, as proposed in the American Teen-LABS study (http://www.cincinnatichildrens.org/ research/divisions/t/teen-labs/default/). Comparison will be made with BMI matched adolescents who participate in the overall project but do not undergo bariatric surgery.

In November 2014 recruitment for the overall project was completed. However, patients interested in bariatric surgery will still be recruited until September 2016. There assessment will be the same as for patients recruited earlier. However, in an amendment in December 2014, the frequency of assessment via questionnaire was reduced from biannually to annually. In addition, a travel reimbursement of 30€ for each study visit was implemented.

Enrollment: 66 patients

Sex: All

Ages: 14 to 24 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI ≥ 35 kg/m2 with severe comorbidity or BMI ≥ 40 kg/m2 with relevant comorbidity
• completed longitudinal growth
• stable social surroundings
• exhaustion of conservative treatment
• participation in the project "Adolescents with extreme Obesity"
• adequate compliance and adherence

Exclusion criteria

• treatable causative condition
• unstable medical, psychosocial or psychiatric comorbidity
• alcohol or drug abuse
• pregnancy
• contraindication for bariatric surgery

Trial design

66 participants in 2 patient groups

bariatric surgery group

Description:

subjects who participate in the overall project and undergo bariatric surgery

Treatment:

Procedure: bariatric surgery

conservative care group

Description:

subjects who participate in the overall project and do not undergo bariatric surgery

Treatment:

Other: conservative care