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临床试验/NCT04198025
NCT04198025Unknown不适用

Evaluating the Association Between Psoas Density Measurement on Preoperative CT Imaging and Postoperative Outcomes

University of Nottingham1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Number of post operative complications (Clavien-Dindo grade 3-4) during inpatient hospital stay.

研究概览

简要总结

Colorectal cancer (CRC) is the 3rd most common cancer worldwide. In the UK, CRC is the 4th most common cancer accounting for 12% of cancers diagnosed each year with approximately 41,300 new cases diagnosed in 2014. Surgery remains the only treatment option that can reliably achieve cure from colorectal cancer and thus nearly 20,000 major bowel resections are performed for this yearly in the UK. Surgery for these cancers however carries risk of major complications and potentially death. Selecting appropriate patients for surgery remains a challenge to cancer teams.

Risk factors exist for complications after surgery for CRC, many of which can be assessed and discussed with the patient prior to surgery, so that any decision to operate is with fully informed consent from the patient. Increasing attention is being paid to a patient's frailty or fitness as one of these risk factors. Our centre has previously shown that measuring the cross-sectional area of the psoas muscle (a large muscle near the spine) from preoperative imaging could predict major complications in colorectal cancer patients (Jones 2015), however specialist software and patient height is required to make this calculation. More recently we have demonstrated that the measurement of the psoas muscle density on preoperative imaging (i.e. routine CT scans that all patients have before surgery to plan treatment), may potentially be useful to predict which patients are at most risk of a major complication (Herrod 2019). If this finding holds true when tested on a larger scale, it could be used to help surgical teams make the decision on whether to offer surgical resection, what kind of operations to perform, how to best support individuals undergoing operation and to ensure that the patient has the most information available to decide what risk they are at by having major surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Patient criteria:
  • Having a major colorectal resection for the treatment of cancer
  • Elective or emergency surgery
  • Adults, defined as age ≥18 years of age (no maximum limit)
  • Had a preoperative CT scan of the abdomen with contrast (portal venous phase)
  • Operation performed between 31st Aug 2013 - 31st Aug 2019

排除标准

  • Not having a preoperative CT scan with contrast

结局指标

主要结局

Number of post operative complications (Clavien-Dindo grade 3-4) during inpatient hospital stay.

时间窗: Through study completion, an average of 10 days.

Recorded post operative complications requiring intervention during post operative stay until initial discharge from hospital.

次要结局

  • Post operative length of stay(Through study completion, usually between 6-10 days.)
  • Mortality(Up to 5 year follow up from operation)
  • Post operative complications beyond hospital discharge.(From hospital discharge to record review (i.e. 30 days, 90 days, 2 - 5 year follow up).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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