跳至主要内容
临床试验/CTRI/2025/10/096093
CTRI/2025/10/096093尚未招募不适用

A Prospective observational study on the relationship of clinical frality score on post operative outcomes in patients undergoing elective and emergency general surgical procedure

The Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2025年10月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
67
试验地点
1
主要终点
To correlate the frailty score of patients undergoing elective and emergency general surgical procedure with post operative outcome

研究概览

简要总结

This study explores the relationship between frailty and postoperative outcomes in elderly patients undergoing general surgical procedures in an Indian hospital setting. Frailty is a clinically recognized condition often associated with aging, characterized by a progressive decline in physiological reserve across multiple organ systems. Although it becomes more common with advancing age, frailty is not an inevitable part of aging, nor is it always progressive.

As the elderly population continues to grow, more older adults are undergoing both elective and emergency surgeries. This raises the importance of identifying frailty preoperatively, as several international studies have shown it to be a strong predictor of poor surgical outcomes. However, there is limited data from India on this subject.

This single-center prospective observational study aims to evaluate frailty using the Clinical Frailty Scale (CFS) in patients aged 65 years and above and to correlate it with postoperative outcomes assessed using the Clavien-Dindo Classification, a widely accepted grading system for surgical complications. The study will include at least 67 patients and apply appropriate statistical methods to analyze the correlation between frailty and outcomes within the first 30 postoperative days.

Inclusion criteria involve elderly inpatients undergoing elective or emergency general surgery with reliable caregivers. Patients undergoing minor outpatient procedures or reoperations from other centers will be excluded. Data will be collected through clinical interviews, caregiver input (when necessary), and hospital records. Statistical analysis will be conducted using IBM SPSS Version 21.

Implications: If the findings show a significant association between higher frailty scores and poor postoperative outcomes, this could support the routine use of frailty assessment in preoperative evaluations. Such assessments would help in risk stratification, tailoring treatment plans, and guiding surgical decision-making in elderly patients. It could also allow for better preoperative counselling regarding potential risks, ultimately improving patient care in the geriatric surgical population in India.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patients (male and female) above 65 years of age who are undergoing elective general surgical procedure as inpatient(group A).
  • Patients (male and female) above the age of 65 years who are undergoing emergency general surgical procedure as inpatient (group B).
  • Those who are assessed by ASA grade.
  • Patients with reliable care givers.

排除标准

  • Patients who are undergoing emergency surgery after elective procedure will not be included in group B.
  • Patients that required reoperation after interventions done in outside hospitals Those who left against medical advice.
  • Those referred to other centres for definitive treatment.
  • Patients undergoing minor outpatient procedures [defined as procedures using local anaesthesia].
  • Patients without reliable care givers.
  • Patients not willing to participate in the study.

结局指标

主要结局

To correlate the frailty score of patients undergoing elective and emergency general surgical procedure with post operative outcome

时间窗: Intermediate

次要结局

未报告次要终点

研究者

发起方
The Indian Council of Medical Research
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Nandhithaa V

SRM MCHRC

研究点 (1)

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