aparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Sleeve Gastrectomy for Severe Obesity in Teenagers: a prospective cohort study.

Recruiting

Conditions: Obesitas
fattness
Obesity
overweight
severe obesity
10003018
10017998

Registration Number: NL-OMON54829

Lead Sponsor: Maxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

(i) Completed a minimum of twelve months in formal lifestyle intervention
and/or pharmacotherapy weight loss program;
(ii) Age 13-17 with Tanner stage >= IV;
(iii) Severe obesity meeting IFSO criteria for bariatric surgery, BMI >=40 kg/m2
with minor comorbidities or BMI >=35 kg/m2 with at least one major comorbidity,
corrected for age and sex according to the IOTF criteria;
(iv) Consensus in the multidisciplinary child obesity team, during the
multidisciplinary meeting, on a strongly motivated participation of the
participant during the lifestyle intervention program so far and in the future
(after the bariatric surgery); the participant must have been fully committed
to be successful in this program and is expected to continue with this effort
after bariatric surgery;
(v) Consensus in the multidisciplinary child obesity team on the diagnosis of
non-responding to multidisciplinary lifestyle interventions for now and the
near future.

Exclusion Criteria

- Unable to consent as appropriate;
- Illiteracy (disability to read and understand questionnaires);
- Secondary obesity, obesity caused by a medical condition;
- Known syndrome (e.g. Prader-Willi syndrome);
- Skeletal immaturity (Tanner stage <=III) - pre-menarche - bone age < 15 years
in boys;
- Ongoing addiction (alcohol, drugs, medication);
- Previous bariatric, gastro-esophageal reflux or gastric surgery;
- Uncontrolled Psychiatric disorders;
- IBD;
- Non-support / consent of both parents / caretakers for children aged 13-15
years.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is a composite outcome:<br /><br>- Proportion of adolescents presented to the national board achieving 20% total<br /><br>weight loss (%TWL) 1 year after surgery;<br /><br>- Incidence of adverse health events and additional surgical intervention<br /><br>during 5 years follow-up.</p><br>

Secondary Outcome Measures