Gastrointestinal CancerNCT07815392
Preoperative Frailty and Postoperative Outcomes in Older Patients Undergoing Surgery for Gastrointestinal Cancer
An observational study of Gastrointestinal Cancer and Frailty, run by Van Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Gastrointestinal Cancer, Frailty
- What is being tested?
- Fried Frailty Index and Clinical Frailty Scale
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Younger than 60 years
- Undergoing emergency surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Van Education and Research Hospital
Van, Van, 65300
İbrahim Doğan, MD, +905313884966, dogan_203@hotmail.com
About this study
Official 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
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.
- Conditions
- Gastrointestinal Cancer, Frailty
- Being tested
- Fried Frailty Index, Clinical Frailty Scale
- Keywords
- Fried Frailty Index, Clinical Frailty Scale, Preoperative Frailty, Postoperative Complications
- Medical subject headings
- Gastrointestinal Neoplasms, Frailty, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fried Frailty IndexDiagnostic 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 ScaleDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Fried Frailty Index; Diagnostic Test: Clinical Frailty Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the date of surgery through postoperative day 90
Secondary outcomes (3)
Postoperative Length of Hospital Stay
The number of days from the date of surgery to hospital discharge.
Measured: From the date of surgery to hospital discharge, assessed up to 90 days after surgery
All-Cause Mortality Within 30 Days After Surgery
The proportion of participants who die from any cause within 30 days after surgery.
Measured: From the date of surgery through postoperative day 30
All-Cause Mortality Within 90 Days After Surgery
The proportion of participants who die from any cause within 90 days after surgery.
Measured: From the date of surgery through postoperative day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Van Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, IBRAHIM DOGAN, Van Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815392
- Sponsor's protocol ID
- 2026/05-05
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07815392
- Acronym / sponsor ID
- 2026/05-05
- Conditions
- Gastrointestinal Cancer, Frailty
- Keywords
- Fried Frailty Index, Clinical Frailty Scale, Preoperative Frailty, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Van Training and Research HospitalOther government
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older Patients Undergoing Gastrointestinal Cancer Surgery | – | Diagnostic Test: Fried Frailty Index, Diagnostic Test: Clinical Frailty ScalePatients 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Younger than 60 years
- Undergoing emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fried Frailty IndexFrailty 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 test | Older Patients Undergoing Gastrointestinal Cancer Surgery |
| Clinical Frailty ScaleFrailty 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. | Diagnostic test | Older Patients Undergoing Gastrointestinal Cancer Surgery |
Primary outcome
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.
3 secondary outcomes
Postoperative Length of Hospital Stay
Time frame: From the date of surgery to hospital discharge, assessed up to 90 days after surgery
All-Cause Mortality Within 30 Days After Surgery
Time frame: From the date of surgery through postoperative day 30
All-Cause Mortality Within 90 Days After Surgery
Time frame: From the date of surgery through postoperative day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Cancer and Frailty, run by Van Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İbrahim Doğan, MD (+905313884966, dogan_203@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Complications (time frame: From the date of surgery through postoperative day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.