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RecruitingNCT07815392Updated Sep 15, 2026

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

An observational study in Gastrointestinal Cancer and Frailty, sponsored by Van Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Van Training and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
60 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gastrointestinal Cancer
  • Frailty

Keywords

  • Fried Frailty Index
  • Clinical Frailty Scale
  • Preoperative Frailty
  • Postoperative Complications
03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Younger than 60 years
  • Undergoing emergency surgery
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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.

05

What researchers measure

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.

    Time frame: From the date of surgery through postoperative day 90

Secondary outcomes

  1. Postoperative Length of Hospital Stay

    The number of days from the date of surgery to hospital discharge.

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

  2. All-Cause Mortality Within 30 Days After Surgery

    The proportion of participants who die from any cause within 30 days after surgery.

    Time frame: From the date of surgery through postoperative day 30

  3. All-Cause Mortality Within 90 Days After Surgery

    The proportion of participants who die from any cause within 90 days after surgery.

    Time frame: From the date of surgery through postoperative day 90

06

Study locations

1 of 1 sites recruiting
  • Van Education and Research Hospital
    Van, Van 65300, Turkey (Türkiye)
    Recruiting
07

Registry details

Key details

Study ID
NCT07815392
Lead sponsor
Van Training and Research Hospital
Responsible party
IBRAHIM DOGAN (General Surgeon and Principal Investigator, Van Training and Research Hospital) — Principal investigator
First posted
Sep 11, 2026
Start date
Jun 1, 2026
Primary completion
Jun 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Sep 15, 2026

Study contacts

İbrahim Doğan, MD
Contact
dogan_203@hotmail.com
+905313884966

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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