Van Education and Research Hospital
Van, 65300, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07815392
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.
Interested in participating?
Request Info60 year and older
All sexes
Observational
Van, 65300, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Frailty will be assessed preoperatively using the Fried Frailty Index. The assessment evaluates established frailty components, including unintentional weight loss, exhaustion, low physical activity, slow walking speed, and reduced grip strength. The assessment will not determine or modify the participant's treatment.
Frailty will be assessed preoperatively using the Clinical Frailty Scale, which classifies the participant's overall level of fitness and frailty based on clinical evaluation. The assessment will not determine or modify the participant's treatment.
Time frame: 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.
Time frame: From the date of surgery to hospital discharge, assessed up to 90 days after surgery
The number of days from the date of surgery to hospital discharge.
Time frame: From the date of surgery through postoperative day 30
The proportion of participants who die from any cause within 30 days after surgery.
Time frame: From the date of surgery through postoperative day 90
The proportion of participants who die from any cause within 90 days after surgery.
Contact information is provided by the study sponsor or research team.
Van Training and Research Hospital
Other Gov
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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