Assessment of Patient Frailty Prior to Thoracic Surgery
2019年5月4日 更新者：University Health Network, Toronto
Assessment of Patient Frailty Prior to Thoracic Surgery: A Feasibility Study
Determine the feasibility of assessment of measures of frailty and determine if these measures provide a clinically important contribution of risk assessment in a population of patients undergoing major thoracic surgery for lung or esophageal cancer.
研究概览
详细说明
Both gastro-esophageal and lung cancers are major causes of morbidity and mortality worldwide.
In Canada the incidence for Esophageal Adenocarcinoma has doubled in the last two decades, while lung cancer is the leading cause of cancer death.
Surgery is a treatment option for these patients; however, esophagectomy in particular, is associated with significant morbidity, mortality and adverse effect on quality of life.
Despite satisfactory standard preoperative testing to evaluate risk for surgery, some patients experience morbidity and never recover fully from surgery.
Frailty assessment may offer a more sensitive measure of a patient's physiologic reserve, which may allow identification of patients who are poor candidates for surgery.
There is a lack of consensus of how best to assess frailty prior to surgery.
This study aims to analyze frailty assessment as a tool for patient selection for surgery.
研究类型
观察性的
注册 (实际的)
40
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Ontario
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Toronto、Ontario、加拿大、M5G 2C4
- University Health Network
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Toronto、Ontario、加拿大、M5G 2C4
- University Health Network (Toronto General Hospital)
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Toronto、Ontario、加拿大、M5G 2C4
- University Health Network: Toronto General Hospital
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Cancer Patients - Lung or Esophageal
描述
Inclusion Criteria:
- Patients with Esophageal or Lung Cancer who will undergo resectional surgery.
Exclusion Criteria:
- Patients undergoing diagnostic or staging procedures or pulmonary wedge excisions will be excluded.
- Patients unable to give informed consent
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Lung Cancer - Frialty Assessment
Patients who will undergo surgery for lung cancer
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Various physiologic and frailty assessment tests
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Esophageal Cancer - Frailty Assessment
Patients who will undergo esophagectomy for esophageal cancer
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Various physiologic and frailty assessment tests
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility Assessment
大体时间：2 years
|
Determine the feasibility of assessment of measures of frailty and determine if these measures provide a clinically important contribution of risk assessment in a population of patients undergoing major thoracic surgery for lung or esophageal cancer.
|
2 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Gail E Darling, MD、University Health Network, Toronto
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.
- Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.
- Chen CH, Ho-Chang, Huang YZ, Hung TT. Hand-grip strength is a simple and effective outcome predictor in esophageal cancer following esophagectomy with reconstruction: a prospective study. J Cardiothorac Surg. 2011 Aug 15;6:98. doi: 10.1186/1749-8090-6-98.
- Robinson TN, Eiseman B, Wallace JI, Church SD, McFann KK, Pfister SM, Sharp TJ, Moss M. Redefining geriatric preoperative assessment using frailty, disability and co-morbidity. Ann Surg. 2009 Sep;250(3):449-55. doi: 10.1097/SLA.0b013e3181b45598.
- Hodari A, Hammoud ZT, Borgi JF, Tsiouris A, Rubinfeld IS. Assessment of morbidity and mortality after esophagectomy using a modified frailty index. Ann Thorac Surg. 2013 Oct;96(4):1240-1245. doi: 10.1016/j.athoracsur.2013.05.051. Epub 2013 Jul 31.
- Talsma AK, Damhuis RA, Steyerberg EW, Rosman C, van Lanschot JJ, Wijnhoven BP. Determinants of improved survival after oesophagectomy for cancer. Br J Surg. 2015 May;102(6):668-75. doi: 10.1002/bjs.9792. Epub 2015 Mar 18.
- Yano Y, Inokuchi T, Kario K. Walking speed is a useful marker of frailty in older persons. JAMA Intern Med. 2013 Feb 25;173(4):325-6. doi: 10.1001/jamainternmed.2013.1629. No abstract available.
- Fritz S, Lusardi M. White paper: "walking speed: the sixth vital sign". J Geriatr Phys Ther. 2009;32(2):46-9. No abstract available. Erratum In: J Geriatr Phys Ther. 2009;32(3):110.
- Sheetz KH, Zhao L, Holcombe SA, Wang SC, Reddy RM, Lin J, Orringer MB, Chang AC. Decreased core muscle size is associated with worse patient survival following esophagectomy for cancer. Dis Esophagus. 2013 Sep-Oct;26(7):716-22. doi: 10.1111/dote.12020. Epub 2013 Jan 25.
- Rogalla P, Meiri N, Hoksch B, Boeing H, Hamm B. Low-dose spiral computed tomography for measuring abdominal fat volume and distribution in a clinical setting. Eur J Clin Nutr. 1998 Aug;52(8):597-602. doi: 10.1038/sj.ejcn.1600612.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年7月29日
初级完成 (实际的)
2018年7月29日
研究完成 (实际的)
2018年11月21日
研究注册日期
首次提交
2016年6月14日
首先提交符合 QC 标准的
2016年6月14日
首次发布 (估计)
2016年6月16日
研究记录更新
最后更新发布 (实际的)
2019年5月7日
上次提交的符合 QC 标准的更新
2019年5月4日
最后验证
2019年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.