Van Education and Research Hospital
Van, 65300, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07817758
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.
Interested in participating?
Request Info60 year and older
All sexes
Observational
Van, 65300, Turkey (Türkiye)
Location status: Recruiting
Sarcopenia is characterized by reduced muscle strength, muscle mass, and physical performance and may be associated with unfavorable postoperative outcomes in older patients with cancer. This prospective, single-center observational cohort study will include patients aged 60 years or older who are scheduled to undergo elective surgery for gastrointestinal cancer at Van Training and Research Hospital.
Before surgery, demographic and clinical characteristics, including age, sex, and cancer diagnosis, will be recorded. Sarcopenia will be evaluated according to the EWGSOP2 criteria using measurements of muscle strength, muscle mass, and physical performance. The SARC-F questionnaire and calf circumference measurement will also be performed as part of the preoperative assessment.
Participants will receive standard surgical and perioperative care, and no treatment or intervention will be assigned by the study protocol. Patients will be observed for 90 days after surgery. Outcomes will include postoperative surgical complications, length of hospital stay, 30-day mortality, and 90-day mortality. Postoperative complications of interest will include anastomotic leakage, wound-related complications, oral intake intolerance, and delayed mobilization. The study will compare these outcomes between patients with and without preoperative sarcopenia and assess whether sarcopenia is independently associated with adverse postoperative outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Preoperative 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.
Time frame: From the date of surgery through 90 days after surgery
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 hospital discharge, an average of 7 days
The duration of postoperative hospitalization, calculated in days from the date of surgery to the date of hospital discharge.
Time frame: Within 30 days after surgery
The number and percentage of participants who die from any cause within 30 days after surgery.
Time frame: Within 90 days after surgery
The number and percentage 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
The Effect of Preoperative Sarcopenia on Postoperative Prognosis in Older Patients With 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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