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Preoperative Frailty and Postoperative Outcomes in Older Patients Undergoing Surgery for Gastrointestinal Cancer

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07815392
Enrollment
100
Registered
2026-09-11
Start date
2026-06-01
Completion date
2027-07-01
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Cancer, Frailty

Keywords

Fried Frailty Index, Clinical Frailty Scale, Preoperative Frailty, Postoperative Complications

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTFried Frailty Index

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.

DIAGNOSTIC_TESTClinical Frailty Scale

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.

Sponsors

Van Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Younger than 60 years * Undergoing emergency surgery

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Postoperative ComplicationsFrom the date of surgery through postoperative day 90The 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.

Secondary

MeasureTime frameDescription
Postoperative Length of Hospital StayFrom the date of surgery to hospital discharge, assessed up to 90 days after surgeryThe number of days from the date of surgery to hospital discharge.
All-Cause Mortality Within 30 Days After SurgeryFrom the date of surgery through postoperative day 30The proportion of participants who die from any cause within 30 days after surgery.
All-Cause Mortality Within 90 Days After SurgeryFrom the date of surgery through postoperative day 90The proportion of participants who die from any cause within 90 days after surgery.

Countries

Turkey (Türkiye)

Contacts

CONTACTİbrahim Doğan, MD
dogan_203@hotmail.com+905313884966

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026