跳至主要内容
临床试验/DRKS00018987
DRKS00018987招募中未知

The FRAGILE” Trial: A Randomized Controlled Trial on the Clinical Efficacy of a Multidisciplinary Coordinated Geriatric Ward in Reducing Postoperative Complications in Elderly Pre-Frail, Frail, and Sarcopenic Patients Undergoing Elective Colorectal Cancer Surgery - The FRAGILE” Trial

KLINIKUM ASCHAFFENBURG, CHIRURGISCHE KLINIK I, ALLGEMEIN-, VISZERAL- UND GEFÄSSCHIRURGIE0 个研究点目标入组 20 人开始时间: 2019年11月7日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • 1.age =70 years old;
  • 2.diagnosis of colorectal cancer;
  • 3.scheduled for elective surgery (for that colorectal cancer);
  • 4.willingness to accept study allocation to either the surgical or the multidisciplinary geriatric ward;
  • 5.Capacity to provide written informed consent;
  • 6.BRASS Score =10.

排除标准

  • 1.a history of prior surgery for colorectal cancer
  • 2.acute colon surgery cases;
  • 3.patients requiring emergency surgery;
  • 4.palliative surgery cases (surgery with the intention of improving quality of life for advanced non-curable disease);
  • 5.nursing home residents requiring full nursing care on admission corresponding to a BRASS Score >30;
  • 6.dementia or other cognitive impairment – at the time of the eligibility screening – sufficient to make completion of the study questionnaires impossible even with the full support of a study nurse;
  • 7.lack of written informed consent;
  • 8.the operating surgeon makes a decision, at the end of the operation and just prior to randomization, that the patient needs post-operative care on the ICU and is not fit for randomization to immediate post-op treatment on either the standard surgical ward or the multidisciplinary geriatric ward, (cf. the section on randomization).

研究者

发起方
KLINIKUM ASCHAFFENBURG, CHIRURGISCHE KLINIK I, ALLGEMEIN-, VISZERAL- UND GEFÄSSCHIRURGIE

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