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临床试验/NL-OMON20900
NL-OMON20900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

Department of General Surgery, Máxima Medical Center, De Run 4600, 5504 DB Veldhoven,The Netherlands0 个研究点目标入组 150 人开始时间: 待定最近更新:

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

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 or more;
  • (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 for example untreated hypothyroidism);
  • - Known syndrome or genetic disorder (such as Prader-Willi syndrome);
  • - Skeletal immaturity (Tanner stage < IV, pre-menarche, bone age < 15 years in boys);
  • - Ongoing addiction (alcohol, drugs, medication);
  • - Previous bariatric, gastro-esophageal reflux or gastric surgery;
  • - Uncontrolled psychiatric disorders;
  • - Inflammatory Bowel Disease (IBD);
  • - Non-support / non-consent of both parents / caretakers of adolescents aged 13-15 years.

研究者

发起方
Department of General Surgery, Máxima Medical Center, De Run 4600, 5504 DB Veldhoven,The Netherlands

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