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临床试验/CTRI/2023/05/052864
CTRI/2023/05/052864已完成不适用

Impact of preoperative frailty in predicting postoperative length of hospital stay in adult patients undergoing major abdominal cancer surgery- a prospective, observational study

Dr BRA Irch AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月6日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
•

研究概览

简要总结

Though age is directly correlated with frailty, it is not an inevitable component. Multiple frailty assessment tools are being created on the basis of clinical judgement which are subjective and time- consuming  Further, none of them is a gold standard for identifying frailty. Most of the frailty indexes require patient cooperation and ability to walk which might not be possible in a subset of frail patients.Hence, an objective, quick tool is required to identify frailty in perioperative settings. Sarcopenia is a functional marker for frailty that can be quantified objectively. Computed tomography is an objective but expensive and resource-intensive tool for assessing sarcopenia by measuring psoas muscle area. Further, it exposes patients to radiations.

Bedside ultrasound is a quick, bedside tool that can determine sarcopenia in perioperative settings without any harmful effects. It can be used to identify frail population preoperatively, and hence, has a potential in risk – stratification of patients.

Previous observational studies are done in western population undergoing heterogenous surgeries to discriminate between frail and not-frail patients using ultrasound. However, the type of surgery can have a confounding impact on the postoperative outcome. Further no studies are conducted on Indian population. Hence, we propose to conduct a prospective, single center, observational study in Indian patients undergoing major abdominal surgery to determine if ultrasound guided quadriceps thickness can be used as a sensitive tool in differentiating between frail and not- frail patients, thereby predicting adverse postoperative outcomes.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • 1.Adults more than 18years old 2.Adult patients undergoing major abdominal cancer surgery defined as surgery having skin incision, an expected operative duration of at least 2 hours, and an expected hospital stay of at least 3 days.

排除标准

  • Refusal / unable to provide written consent 2.

结局指标

主要结局

•

时间窗: 1. till hospital stay

1. Effect of frailty as assessed by Fried Frailty Index on Hospital LOS

时间窗: 1. till hospital stay

次要结局

  • 1. To find the optimal cut off values of quadriceps thickness and rectus femoris CSA using ultrasonography to classify frail and not frail(2.Postoperative surgical complications as defined by Clavien – Dindo classification)

研究者

发起方
Dr BRA Irch AIIMS New Delhi
申办方类型
Government medical college

研究点 (1)

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