FrailtyNCT06889714
Investigation of the Effects of Frailty and Sarcopenia on Postoperative Recovery and Complications in Geriatric Patients
An observational study of Frailty and Sarcopenia, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
After obtaining ethical approval, 42 patients with American Society of Anesthesiologists (ASA) scores I-III who were scheduled for surgery under general anesthesia were included in our prospective study. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Sarcopenia
- What is being tested?
- ultrasonography
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2023to 20 Jul 2024
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 42 patients over 60 years of age with ASA score I-III who were to undergo colorectal malignancy surgery under general anesthesia
Who may be able to join
- patients over 60 years of age who are undergoing colorectal malignancy surgery under general anesthesia
- patients willing to participate in the study
- Patients with ASA score I-III
Who cannot join
- Patients with Parkinson's disease,
- Alzheimer's disease,
- history of cerebrovascular events,
- neuromuscular disease,
- cognitive dysfunction,
- severe liver disease,
Show all 10Show fewer
- severe heart disease,
- impaired cooperation due to kidney disease,
- emergency and trauma patients,
- patients with bilateral lower extremity amputations
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Eskisehir Osmangazi
Eskişehir, Odunpazarı, 26040
About this study
Official title: Investigation of the Effects of Frailty and Sarcopenia on Postoperative Recovery and Complications in Geriatric Patients Undergoing Colorectal Cancer Surgery
After obtaining ethical approval, 42 patients with American Society of Anesthesiologists (ASA) scores I-III who were scheduled for surgery under general anesthesia were included in our prospective study. Patients were monitored in the preoperative preparation room in the operating room and frailty was assessed using the FRAIL scale and sarcopenia was assessed using the STAR ratio. The thickness of the rectus femoris and vastus intermedius muscles of the patients was measured and recorded by ultrasonography. Thigh lengths were measured and recorded. Rectus Femoris/Thigh Length (RF/B), Vastus Intermedius/Thigh Length (VI/B), and Total Muscle Thickness/Thigh Length (T/B) were calculated and recorded. Patients were followed up according to the Modified Aldrete Score after surgery in the anesthesia recovery unit, and the time to reach 9-10 points was recorded, and the time to leave the recovery unit was recorded. Postoperatively, complications were followed up according to the Clavien-Dindo Classification, and discharge times from the hospital were recorded.
Read the detailed description
Frailty is a clinically identifiable state of heightened vulnerability resulting from age-related declines in physiological systems and functions, leading to impaired resilience to stressors. Frailty is highly prevalent among the elderly and is associated with an increased risk of falls, disability, hospitalization, and mortality. Magnetic resonance imaging (MRI) and computed tomography (CT) are considered the gold standard for sarcopenia diagnosisCT is also limited due to radiation exposure and similar logistical constraints. In contrast, ultrasonography (USG) is portable, cost-effective, and can be performed at the bedside without radiation exposure.
Using high-frequency ultrasound probes, peripheral muscle tissues and their dimensions can be rapidly assessed.
- Conditions
- Frailty, Sarcopenia
- Being tested
- ultrasonography
- Keywords
- geriatric anesthesia, sarcopenia, ultrasonography, postoperative complications, quadriceps femoris
- Medical subject headings
- Frailty, Sarcopenia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyDevice
Right thigh length (between the right femur greater trochanter and patella) was measured and recorded while the patients were lying supine. A linear transducer (Philips Affiniti 50, Philips Medical Systems, Seattle, WA, United States) was used for ultrasonographic measurements. The rectus femoris (RF) and vastus intermedius (VI) were visualized with the feather-touch technique after a generous amount of ultrasound gel was sprayed in the center of the right thigh, and the thickness of the muscles was determined and recorded using ultrasonography software. After these measurements, the rectus femoris-to-thigh length ratio (RF/B), vastus intermedius-to-thigh length ratio (VI/B), and total muscle thickness-to-thigh length ratio (T/B) were calculated and recorded.
What is being measured
The primary outcome is the main question the study is designed to answer.
age
years old
Measured: 1 year
sex
female, male
Measured: 1 year
height
meter
Measured: 1 year
body weight
kg
Measured: 1. year
educational status
primary school graduate, middle school graduate, high school graduate, university graduate
Measured: 1 year
marital status
married, single, widowed
Measured: 1 year
ASA score
American Society of Anesthesiologists' Classification (ASA 1,2,3,4,5)
Measured: 1 year
rectus femoris muscle thickness
cm
Measured: 1 year
vastus intermedius(VI) thickness
cm
Measured: 1 year
rectus femoris-to-thigh length ratio
ratio
Measured: 1 year
vastus intermedius-thigh length ratio
ratio
Measured: 1 year
total muscle thickness to thigh length ratio
ratio
Measured: 1 year
frailty score
0-NORMAL, 1-2 PRE-FRAİL, 3-5 FRAİL
Measured: 1 year
recovery time from anesthesia
minutes
Measured: 1 year
hospital discharge time
days
Measured: 1 year
Modified Clavien-Dindo Classification
1, 2, 3A, 3B, 4A, 4B, 5
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start20 Jul 2023
- Primary completion20 Jul 2024
- Study completion20 Jul 2024
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferda YAMAN, Eskisehir Osmangazi University
- Investigators
- ferda yaman, Assoc prof, Principal investigator, University of Eskişehir Osmangazi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889714
- Sponsor's protocol ID
- Eskisehir
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Frailty and Sarcopenia on Postoperative Recovery and Complications in Geriatric Patients Undergoing Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT06889714
- Acronym / sponsor ID
- Eskisehir
- Conditions
- Frailty, Sarcopenia
- Keywords
- geriatric anesthesia, sarcopenia, ultrasonography, postoperative complications, quadriceps femoris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 21 Mar 2025 (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.
After obtaining ethical approval, 42 patients with American Society of Anesthesiologists (ASA) scores I-III who were scheduled for surgery under general anesthesia were included in our prospective study. Patients were monitored in the preoperative preparation room in the operating room and frailty was assessed using the FRAIL scale and sarcopenia was assessed using the STAR ratio. The thickness of the rectus femoris and vastus intermedius muscles of the patients was measured and recorded by ultrasonography. Thigh lengths were measured and recorded. Rectus Femoris/Thigh Length (RF/B), Vastus Intermedius/Thigh Length (VI/B), and Total Muscle Thickness/Thigh Length (T/B) were calculated and recorded. Patients were followed up according to the Modified Aldrete Score after surgery in the anesthesia recovery unit, and the time to reach 9-10 points was recorded, and the time to leave the recovery unit was recorded. Postoperatively, complications were followed up according to the Clavien-Dindo Classification, and discharge times from the hospital were recorded.
Detailed description
Frailty is a clinically identifiable state of heightened vulnerability resulting from age-related declines in physiological systems and functions, leading to impaired resilience to stressors. Frailty is highly prevalent among the elderly and is associated with an increased risk of falls, disability, hospitalization, and mortality. Magnetic resonance imaging (MRI) and computed tomography (CT) are considered the gold standard for sarcopenia diagnosisCT is also limited due to radiation exposure and similar logistical constraints. In contrast, ultrasonography (USG) is portable, cost-effective, and can be performed at the bedside without radiation exposure.
Using high-frequency ultrasound probes, peripheral muscle tissues and their dimensions can be rapidly assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 42 patients over 60 years of age with ASA score I-III who were to undergo colorectal malignancy surgery under general anesthesia
Key inclusion criteria (3 listed)
- patients over 60 years of age who are undergoing colorectal malignancy surgery under general anesthesia
- patients willing to participate in the study
- Patients with ASA score I-III
Key exclusion criteria (10 listed)
- Patients with Parkinson's disease,
- Alzheimer's disease,
- history of cerebrovascular events,
- neuromuscular disease,
- cognitive dysfunction,
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 |
|---|---|---|
| ultrasonographyRight thigh length (between the right femur greater trochanter and patella) was measured and recorded while the patients were lying supine. A linear transducer (Philips Affiniti 50, Philips Medical Systems, Seattle, WA, United States) was used for ultrasonographic measurements. The rectus femoris (RF) and vastus intermedius (VI) were visualized with the feather-touch technique after a generous amount of ultrasound gel was sprayed in the center of the right thigh, and the thickness of the muscles was determined and recorded using ultrasonography software. After these measurements, the rectus femoris-to-thigh length ratio (RF/B), vastus intermedius-to-thigh length ratio (VI/B), and total muscle thickness-to-thigh length ratio (T/B) were calculated and recorded. | Device | – |
Primary outcome
age
Time frame: 1 year
years old
sex
Time frame: 1 year
female, male
height
Time frame: 1 year
meter
body weight
Time frame: 1. year
kg
educational status
Time frame: 1 year
primary school graduate, middle school graduate, high school graduate, university graduate
marital status
Time frame: 1 year
married, single, widowed
ASA score
Time frame: 1 year
American Society of Anesthesiologists' Classification (ASA 1,2,3,4,5)
rectus femoris muscle thickness
Time frame: 1 year
cm
vastus intermedius(VI) thickness
Time frame: 1 year
cm
rectus femoris-to-thigh length ratio
Time frame: 1 year
ratio
vastus intermedius-thigh length ratio
Time frame: 1 year
ratio
total muscle thickness to thigh length ratio
Time frame: 1 year
ratio
frailty score
Time frame: 1 year
0-NORMAL, 1-2 PRE-FRAİL, 3-5 FRAİL
recovery time from anesthesia
Time frame: 1 year
minutes
hospital discharge time
Time frame: 1 year
days
Modified Clavien-Dindo Classification
Time frame: 1 year
1, 2, 3A, 3B, 4A, 4B, 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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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.
ferda yaman, Assoc prof principal investigator
University of Eskişehir Osmangazi
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 and Sarcopenia, run by Eskisehir Osmangazi 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 10 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: finished, as of the sponsor's last update on 27 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
age (time frame: 1 year). The study lists 16 primary outcomes in all. 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 27 Mar 2025.