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

NCT07815392 | Recruiting

• 1 other identifier: 2026/05-05
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Cancer; Frailty

Keywords

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

Outcome Measures

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.

  From the date of surgery through postoperative day 90

Secondary Outcomes (3)

• Postoperative Length of Hospital Stay

  From the date of surgery to hospital discharge, assessed up to 90 days after surgery

• All-Cause Mortality Within 30 Days After Surgery

  From the date of surgery through postoperative day 30

• All-Cause Mortality Within 90 Days After Surgery

  From the date of surgery through postoperative day 90

Study Arms (1)

Older Patients Undergoing Gastrointestinal Cancer Surgery

Patients aged 60 years or older who are scheduled to undergo elective surgery for gastrointestinal cancer. Preoperative frailty will be assessed using the Fried Frailty Index and the Clinical Frailty Scale. Participants will receive routine clinical care and will be followed for 90 days after surgery to record postoperative complications, length of hospital stay, and mortality.

Diagnostic Test: Fried Frailty Index; Diagnostic Test: Clinical Frailty Scale

Interventions

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.

Older Patients Undergoing Gastrointestinal Cancer Surgery

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.

Older Patients Undergoing Gastrointestinal Cancer Surgery

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Younger than 60 years
• Undergoing emergency surgery

Sponsors & Collaborators

• Van Training and Research Hospital: lead

Study Sites (1)

Van Education and Research Hospital

Van, Van, 65300, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Frailty; Postoperative Complications

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

İbrahim Doğan, MD

CONTACT

+905313884966; dogan_203@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgeon and Principal Investigator

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

TU (1)