Preoperative Frailty and Postoperative Outcomes in Older Patients Undergoing Surgery for Gastrointestinal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorVan Training and Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Younger than 60 years
Undergoing emergency surgery
Trial population
The study population will consist of patients aged 60 years or older with gastrointestinal cancer who are scheduled to undergo elective surgery at the General Surgery Clinic of Van Training and Research Hospital. Preoperative frailty will be assessed using the Fried Frailty Index and the Clinical Frailty Scale, and participants will be followed for 90 days after surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Fried Frailty Index
Diagnostic testFrailty 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.
Clinical Frailty Scale
Diagnostic testFrailty 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Older Patients Undergoing Gastrointestinal Cancer Surgery2 interventions
Trial outcomes
Primary outcomes
1
Incidence of Postoperative Complications
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 through postoperative day 90Secondary outcomes
1
Postoperative Length of Hospital Stay
The number of days from the date of surgery to hospital discharge.
Time frame
From the date of surgery to hospital discharge, assessed up to 90 days after surgery2
All-Cause Mortality Within 30 Days After Surgery
The proportion of participants who die from any cause within 30 days after surgery.
Time frame
From the date of surgery through postoperative day 303
All-Cause Mortality Within 90 Days After Surgery
The proportion of participants who die from any cause within 90 days after surgery.
Time frame
From the date of surgery through postoperative day 90Sponsors and contacts
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Source ClinicalTrials.gov