NL-OMON54829招募中不适用
aparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Sleeve Gastrectomy for Severe Obesity in Teenagers: a prospective cohort study. - TEEN-BEST
Maxima Medisch Centrum0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 17(—)
入选标准
- •(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.
排除标准
- •- 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
- •- Ongoing addiction (alcohol, drugs, medication);
- •- Previous bariatric, gastro-esophageal reflux or gastric surgery;
- •- Uncontrolled Psychiatric disorders;
- •- Non-support / consent of both parents / caretakers for children aged 13-15
研究者
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