跳至主要内容
临床试验/NCT03682133
NCT03682133终止不适用

Practice Variation in Colon Cancer Surgery Care in Older Patients

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年6月27日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
20
试验地点
2
主要终点
Truncated logistic regression analysis

研究概览

简要总结

This study will answer the question what the practice variation is (in terms of efficiency) in primary colon surgery on patients of 75 years and above related to the application of different modalities of prehabilitation across the Netherlands.

详细描述

Rationale: Prehabilitation has shown promising results in orthopedic, cardiothoracic and abdominal surgery. However, there is still a lack of data supporting cost-effectiveness of prehabilitation in colon cancer surgery in older patients. Therefore the Dutch guidelines still restrict prehabilitation for research settings.

Objective: This study will answer the question what the practice variation is (in terms of efficiency) in primary colon surgery on patients of 75 years and above related to the application of different modalities of prehabilitation across the Netherlands. Besides, it will show what service factors (including prehabilitation) determine the technical efficiency of primary colon surgery for these patients of 75 years and above.

Study design: This study is a multicenter observational study based on questionnaires and existing data sources, aimed at including 24 different hospitals, of which structural, process and outcome data related to prehabilitation and colon cancer surgery will be registered.

Study population: Patients aged 75 years and above, 10 per participating hospital, who underwent colon cancer surgery in one of the participating hospitals, where prehabilitation is or is not applied. All patients will be followed with questionnaires focusing on process and outcome measures for the hospital period and three months after discharge.

Intervention: Whether or not the intervention (prehabilitation) is judged as part of daily practice in a participating hospital is based on a predefined definition of oncological surgical prehabilitation. The care as given in a participating hospital is according to the local guideline and will not be changed for this study. According to our definition prehabilitation consists at least of a minimum of 2 weeks exercise therapy and a review of the patients nutritional status at least 2 weeks before surgery.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 75 years and above
  • Scheduled for colon cancer surgery

排除标准

  • Not receiving surgery
  • Hematogenous metastasis
  • Pretreatment; chemotherapy or radiotherapy
  • Rectal cancer

结局指标

主要结局

Truncated logistic regression analysis

时间窗: up to 4 months

Truncated regression analysis will be performed to identify which explanatory variable(s) predict technical efficiency. Possible explanatory variables will be casemix, yes/ no availability of shared care with geriatrics, yes/no availability of prehabilitation in unimodal or multimodal version, mean volume of older colon cancer patients per practice, propensity score for the frailty of the case mix based on age/sex/disabilities, yes/no availability of laparoscopic colon cancer surgery.

Technical efficiency measured using Data Envelopment Analysis (DEA)

时间窗: up to 4 months

Multiple measurements will be aggregated to arrive at one reported value; technical efficiency. Measurements will be invested care, length of stay, mortality, complication rate and PROMs.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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