Preoperative Sarcopenia and Postoperative Outcomes in Older Patients With Gastrointestinal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorVan Training and Research Hospital
About this trial
This prospective cohort study aims to evaluate the association between preoperative sarcopenia and postoperative outcomes in patients aged 60 years or older undergoing elective surgery for gastrointestinal cancer. Sarcopenia will be assessed preoperatively using the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria, including muscle strength, muscle mass, and physical performance, together with the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire and calf circumference measurement. Participants will be followed for 90 days after surgery. Postoperative complications, length of hospital stay, and 30-day and 90-day mortality will be evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 60 years or older
Diagnosis of gastrointestinal system cancer
Scheduled to undergo elective surgical treatment
Considered operable based on routine clinical evaluation
Disqualifiers
Age younger than 60 years
Undergoing emergency surgery
Inability to complete the required preoperative sarcopenia assessment
Trial population
Patients aged 60 years or older with gastrointestinal system cancer who are scheduled to undergo elective surgery at the General Surgery Clinic of Van Training and Research Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Preoperative Sarcopenia Status
Other interventionPreoperative sarcopenia status will be determined according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria using assessments of muscle strength, muscle mass, and physical performance. The SARC-F questionnaire and calf circumference measurement will also be performed. No therapeutic intervention will be assigned by the study protocol.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Participants With Preoperative Sarcopenia1 intervention
Group B: Participants Without Preoperative Sarcopenia1 intervention
Trial outcomes
Primary outcomes
1
Incidence of postoperative complications
The number and percentage of participants who experience at least one postoperative complication, including anastomotic leakage, wound-related complications, oral intake intolerance, delayed mobilization, or another surgery-related complication. Complications will be identified through inpatient records and follow-up assessments.
Time frame
From the date of surgery through 90 days after surgerySecondary outcomes
1
Length of hospital stay
The duration of postoperative hospitalization, calculated in days from the date of surgery to the date of hospital discharge.
Time frame
From the date of surgery through hospital discharge, an average of 7 days2
30-day all-cause mortality
The number and percentage of participants who die from any cause within 30 days after surgery.
Time frame
Within 30 days after surgery3
90-day all-cause mortality
The number and percentage of participants who die from any cause within 90 days after surgery.
Time frame
Within 90 days after surgerySponsors and contacts
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Source ClinicalTrials.gov