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临床试验/NL-OMON54829
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

发起方
Maxima Medisch Centrum

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