Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07815392

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Van Education and Research Hospital

Van, 65300, Turkey (Türkiye)

Location status: Recruiting

Location contact

İbrahim Doğan, MD

CONTACT

[email protected]

+905313884966

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fried Frailty Index

Diagnostic Test

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.

Clinical Frailty Scale

Diagnostic Test

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.

Primary outcomes

  1. Incidence of Postoperative Complications

    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.

Secondary outcomes

  1. Postoperative Length of Hospital Stay

    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.

  2. All-Cause Mortality Within 30 Days After Surgery

    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.

  3. All-Cause Mortality Within 90 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.

Study contacts

Contact information is provided by the study sponsor or research team.

İbrahim Doğan, MD

CONTACT

[email protected]

+905313884966

Sponsors and collaborators

Lead sponsor

Van Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.