跳至主要内容
临床试验/NCT07815392
NCT07815392招募中不适用

Prognostic Value of the Fried Frailty Index and Clinical Frailty Scale for Postoperative Length of Hospital Stay, Mortality, and Complications in Older Patients Undergoing Surgery for Gastrointestinal Cancer: A Prospective Cohort Study

Van Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Incidence of Postoperative Complications

研究概览

简要总结

This prospective observational cohort study will evaluate whether preoperative frailty, assessed using the Fried Frailty Index and the Clinical Frailty Scale, is associated with postoperative outcomes in patients aged 60 years or older undergoing elective surgery for gastrointestinal cancer. Participants will be followed for 90 days after surgery. Postoperative complications, length of hospital stay, and mortality at 30 and 90 days will be recorded. The study aims to determine the prognostic value of these frailty assessment tools for identifying patients at increased risk of adverse postoperative outcomes.

详细描述

Frailty is associated with reduced physiological reserve and may increase the risk of adverse outcomes following major surgery, particularly in older patients with cancer. Preoperative recognition of frailty may assist clinicians in risk assessment, perioperative planning, and postoperative monitoring.

This single-center prospective observational cohort study will include approximately 80-100 patients aged 60 years or older who are scheduled to undergo elective surgery for gastrointestinal cancer at Van Training and Research Hospital. Before surgery, each participant's frailty status will be assessed using the Fried Frailty Index and the Clinical Frailty Scale. Demographic and clinical characteristics, including age, sex, cancer diagnosis, and relevant perioperative variables, will also be recorded.

Participants will receive routine clinical care, and no treatment or surgical intervention will be assigned by the study protocol. Patients will be followed for 90 days after surgery. Recorded postoperative outcomes will include length of hospital stay, surgical and medical complications, 30-day mortality, and 90-day mortality. The associations between preoperative frailty scores and postoperative outcomes will be analyzed to evaluate and compare the prognostic performance of the two frailty assessment tools.

研究设计

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

入排标准

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

入选标准

  • Aged 60 years or older
  • Diagnosed with gastrointestinal cancer
  • Considered operable and scheduled to undergo elective surgery
  • Evaluated at the General Surgery Clinic of Van Training and Research Hospital
  • Willing to participate and provide informed consent

排除标准

  • Younger than 60 years
  • Undergoing emergency surgery

研究组 & 干预措施

Older Patients Undergoing Gastrointestinal Cancer Surgery

Patients aged 60 years or older who are scheduled to undergo elective surgery for gastrointestinal cancer. Preoperative frailty will be assessed using the Fried Frailty Index and the Clinical Frailty Scale. Participants will receive routine clinical care and will be followed for 90 days after surgery to record postoperative complications, length of hospital stay, and mortality.

干预措施: Fried Frailty Index (Diagnostic Test)

Older Patients Undergoing Gastrointestinal Cancer Surgery

Patients aged 60 years or older who are scheduled to undergo elective surgery for gastrointestinal cancer. Preoperative frailty will be assessed using the Fried Frailty Index and the Clinical Frailty Scale. Participants will receive routine clinical care and will be followed for 90 days after surgery to record postoperative complications, length of hospital stay, and mortality.

干预措施: Clinical Frailty Scale (Diagnostic Test)

结局指标

主要结局

Incidence of Postoperative Complications

时间窗: From the date of surgery through postoperative day 90

The proportion of participants who develop at least one postoperative surgical or medical complication. Recorded complications will include anastomotic leakage, wound-related complications, intolerance of oral intake, delayed mobilization, and other clinically documented postoperative complications.

次要结局

  • Postoperative Length of Hospital Stay(From the date of surgery to hospital discharge, assessed up to 90 days after surgery)
  • All-Cause Mortality Within 30 Days After Surgery(From the date of surgery through postoperative day 30)
  • All-Cause Mortality Within 90 Days After Surgery(From the date of surgery through postoperative day 90)

研究者

发起方
Van Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

IBRAHIM DOGAN

General Surgeon and Principal Investigator

Van Training and Research Hospital

研究点 (1)

Loading locations...

相似试验