FrailtyNCT06182228
Effectıvenes Of Frail Scale And Daily Lıfe Activity Assesment For Major Abdominal Surgery Patients
An observational study of Frailty, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
The effectiveness of assessing postoperative outcomes in eldely patients undergoing major abdominal surgery through the Frailty Scale and Katz Activities of Daily Living evaluation is investigated in individuals aged 65-85. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Frailty
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 30 Mar 2024
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients aged 65-85 who underwent major abdominal surgery
Who may be able to join
- Being between the ages of 65-85
- Patients requiring elective major abdominal surgery
- Approval of the informed consent form
Who cannot join
- Those under the age of 65 and over the age of 85
- Those with cognitive dysfunction
- Those who did not approve of participating in the study
- Patients requiring urgent surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness Of Frail Scale And Daily Life Activity Assessments In Determining Postoperative Results In Patients Between 65-85 Years Of Age Which Are Planned For Major Abdominal Surgery
The effectiveness of assessing postoperative outcomes in eldely patients undergoing major abdominal surgery through the Frailty Scale and Katz Activities of Daily Living evaluation is investigated in individuals aged 65-85. The secondary objective is to determine the prevalence of frailty in patients undergoing surgical procedures.
Read the detailed description
People's life expectancy is increasing rapidly in line with technological progress in the quality of medical care. According to projections by the World Health Organization, it is estimated that by 2030, one in six people worldwide will be aged 60 and above. This figure is expected to reach 2.1 bilion by 2050, with the number of individuals aged 80 and above reaching 426 million.Surgical interventions in elderly patients are associated with increased rates of major complictions, prolonged hospital stays, unplanned readmissions and transfers to rehabilitation center, indicating adverse health outcomes. Therefore, considering the population growth rate, it is inevitable to develop new methods i planning surgical interventions for the elderly. As this point, challenges in surgical planning for individuals fallling under the definition of " frail eldely" become more pronounced. 'Frailty' is a biological syndrome resulting from cumulative declines in multiple physiological systems, leading to vulnerability aganist adverse outcomes, characterized by areduction in reserves and resistance to stress factors. This concept is considered an independent risk factor in predicting and managing postoperative adverse outcomes, beyond aging and comorbidity conditions.Taking into account its determinative impact on surgical outcomes, focusing on the planning of surgical procudures and optimizing postoperative results for patients falling under the definition of "frail elderly" can provide a suitable perspective. Numerous tools have been developed in the literature to measure frailty; however, there is no standardized and approved method for perioperative assessment.The FRAIL Scale, frequently applied in clinical practice to determine levels of frailty, is a practical and straightforward tool. The application, scoring and interpretation of this brief measurement based on interviews are easy. Another easy way to assess the health status of the elderly is to perform a functional assesment that indicates vulnerability and provides objective data. Among the tools used to assess basic activities of daily living, the Katz Index of Independence in Activities of Daily Living is one of the best-known and most commonly used scales clinical practice and research studies.The study aims to determine the effectiveness of FRAIL Scale and Katz Activities of Daily Living assessments in predicting postoperative outcomes, including hospital stay,intensive care needs, readmission rates and duration, reoperation necessity and their associations with morbidity and mortality in patients aged 65-85 undergoing major abdominal surgery and identified in the "frail elderly" stage.
- Conditions
- Frailty
- Keywords
- Surgical patient
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the FRAIL scale in predicting postoperative outcomes
5 questions of the FRAIL Scale were asked.Questions that evaluated fatigue(How tired have you felt in the last 4 weeks?),resistance(Do you have difficulty climbing 10 flights of stairs on your own, without using any assistive devices, without resting?), wandering (Do you have difficulty walking a few hundred meters on your own and without using an assistive device?), diseases ( How many of the 11 diseases we will list have been told to you by a doctor before as your "disease"? Hypertension, diabetes, cancer (other than minor skin cancer), chronic lung disease, myocardial infarction, congestive heart failure, angina, asthma, arthritis, kidney disease and stroke) and unintentional weight loss (Have you lost 5% of your body weight in the last year?) were given "0" and "1" points. At the end of a total of 5 questions, those who scored 0 points were considered "non-frail", those who scored 1-2 points were considered "pre-frail", and those who scored 3-5 points were considered "frail".
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Jun 2022
- Primary completion1 Jun 2022
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bengü Araz, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182228
- Sponsor's protocol ID
- 2011-KAEK-26/433
- Status last verified
- Feb 2024
- First submitted
- 15 Nov 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I have not decided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness Of Frail Scale And Daily Life Activity Assessments In Determining Postoperative Results In Patients Between 65-85 Years Of Age Which Are Planned For Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06182228
- Acronym / sponsor ID
- 2011-KAEK-26/433
- Conditions
- Frailty
- Keywords
- Surgical patient
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 26 Dec 2023 (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.
The effectiveness of assessing postoperative outcomes in eldely patients undergoing major abdominal surgery through the Frailty Scale and Katz Activities of Daily Living evaluation is investigated in individuals aged 65-85. The secondary objective is to determine the prevalence of frailty in patients undergoing surgical procedures.
Detailed description
People's life expectancy is increasing rapidly in line with technological progress in the quality of medical care. According to projections by the World Health Organization, it is estimated that by 2030, one in six people worldwide will be aged 60 and above. This figure is expected to reach 2.1 bilion by 2050, with the number of individuals aged 80 and above reaching 426 million.Surgical interventions in elderly patients are associated with increased rates of major complictions, prolonged hospital stays, unplanned readmissions and transfers to rehabilitation center, indicating adverse health outcomes. Therefore, considering the population growth rate, it is inevitable to develop new methods i planning surgical interventions for the elderly. As this point, challenges in surgical planning for individuals fallling under the definition of " frail eldely" become more pronounced. 'Frailty' is a biological syndrome resulting from cumulative declines in multiple physiological systems, leading to vulnerability aganist adverse outcomes, characterized by areduction in reserves and resistance to stress factors. This concept is considered an independent risk factor in predicting and managing postoperative adverse outcomes, beyond aging and comorbidity conditions.Taking into account its determinative impact on surgical outcomes, focusing on the planning of surgical procudures and optimizing postoperative results for patients falling under the definition of "frail elderly" can provide a suitable perspective. Numerous tools have been developed in the literature to measure frailty; however, there is no standardized and approved method for perioperative assessment.The FRAIL Scale, frequently applied in clinical practice to determine levels of frailty, is a practical and straightforward tool. The application, scoring and interpretation of this brief measurement based on interviews are easy. Another easy way to assess the health status of the elderly is to perform a functional assesment that indicates vulnerability and provides objective data. Among the tools used to assess basic activities of daily living, the Katz Index of Independence in Activities of Daily Living is one of the best-known and most commonly used scales clinical practice and research studies.The study aims to determine the effectiveness of FRAIL Scale and Katz Activities of Daily Living assessments in predicting postoperative outcomes, including hospital stay,intensive care needs, readmission rates and duration, reoperation necessity and their associations with morbidity and mortality in patients aged 65-85 undergoing major abdominal surgery and identified in the "frail elderly" stage.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients aged 65-85 who underwent major abdominal surgery
Key inclusion criteria (3 listed)
- Being between the ages of 65-85
- Patients requiring elective major abdominal surgery
- Approval of the informed consent form
Key exclusion criteria (4 listed)
- Those under the age of 65 and over the age of 85
- Those with cognitive dysfunction
- Those who did not approve of participating in the study
- Patients requiring urgent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness of the FRAIL scale in predicting postoperative outcomes
Time frame: 1 month
5 questions of the FRAIL Scale were asked.Questions that evaluated fatigue(How tired have you felt in the last 4 weeks?),resistance(Do you have difficulty climbing 10 flights of stairs on your own, without using any assistive devices, without resting?), wandering (Do you have difficulty walking a few hundred meters on your own and without using an assistive device?), diseases ( How many of the 11 diseases we will list have been told to you by a doctor before as your "disease"? Hypertension, diabetes, cancer (other than minor skin cancer), chronic lung disease, myocardial infarction, congestive heart failure, angina, asthma, arthritis, kidney disease and stroke) and unintentional weight loss (Have you lost 5% of your body weight in the last year?) were given "0" and "1" points. At the end of a total of 5 questions, those who scored 0 points were considered "non-frail", those who scored 1-2 points were considered "pre-frail", and those who scored 3-5 points were considered "frail".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No. I have not decided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Frailty, run by Uludag University 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the FRAIL scale in predicting postoperative outcomes (time frame: 1 month). 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 14 Feb 2024.