- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06889714
Investigation of the Effects of Frailty and Sarcopenia on Postoperative Recovery and Complications in Geriatric Patients
Investigation of the Effects of Frailty and Sarcopenia on Postoperative Recovery and Complications in Geriatric Patients Undergoing Colorectal Cancer Surgery
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Odunpazarı
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Eski̇şehi̇r, Odunpazarı, Turkey, 26040
- University of Eskisehir Osmangazi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with Parkinson's disease,
- Alzheimer's disease,
- history of cerebrovascular events,
- neuromuscular disease,
- cognitive dysfunction,
- severe liver disease,
- severe heart disease,
- impaired cooperation due to kidney disease,
- emergency and trauma patients,
- patients with bilateral lower extremity amputations
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
age
Time Frame: 1 year
|
years old
|
1 year
|
|
sex
Time Frame: 1 year
|
female, male
|
1 year
|
|
height
Time Frame: 1 year
|
meter
|
1 year
|
|
body weight
Time Frame: 1. year
|
kg
|
1. year
|
|
educational status
Time Frame: 1 year
|
primary school graduate, middle school graduate, high school graduate, university graduate
|
1 year
|
|
marital status
Time Frame: 1 year
|
married, single, widowed
|
1 year
|
|
rectus femoris muscle thickness
Time Frame: 1 year
|
cm
|
1 year
|
|
vastus intermedius(VI) thickness
Time Frame: 1 year
|
cm
|
1 year
|
|
rectus femoris-to-thigh length ratio
Time Frame: 1 year
|
ratio
|
1 year
|
|
vastus intermedius-thigh length ratio
Time Frame: 1 year
|
ratio
|
1 year
|
|
total muscle thickness to thigh length ratio
Time Frame: 1 year
|
ratio
|
1 year
|
|
frailty score
Time Frame: 1 year
|
0-NORMAL, 1-2 PRE-FRAİL, 3-5 FRAİL
|
1 year
|
|
recovery time from anesthesia
Time Frame: 1 year
|
minutes
|
1 year
|
|
hospital discharge time
Time Frame: 1 year
|
days
|
1 year
|
|
Modified Clavien-Dindo Classification
Time Frame: 1 year
|
1, 2, 3A, 3B, 4A, 4B, 5
|
1 year
|
|
ASA score
Time Frame: 1 year
|
American Society of Anesthesiologists' Classification (ASA 1,2,3,4,5)
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ferda yaman, Assoc prof, University of Eskisehir Osmangazi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Eskisehir
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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