- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06121791
Abdominal Skeletal Muscle Compartments in Turkish Children
Establishment Reference Values for Abdominal Skeletal Muscle Compartments in Turkish Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim in this study is to determine reference values for Turkish children by evaluating the abdominal region skeletal muscle area (psoas muscle, paraspinal muscles and total skeletal muscle in the section) obtained from cross-sectional CT images.
Material Method of the Research The study was planned as a retrospective study. Patients under 18 years of age who are admitted to Istanbul Province Bağcılar Training and Research Hospital with acute abdominal pain or acute trauma between May 5, 2017 and May 5, 2023 and who underwent abdominal computed tomography (CT) imaging on this date of application will be scanned through the hospital information management system. Past diagnoses of these patients will be questioned and those with chronic diseases will be excluded from the study.
CT images of the patients will be retrieved from the PACS database. From the sections taken at the L3-L4, L4-L5 levels, the cross-sectional area of the psoas muscle, paraspinal muscles and the total skeletal muscles in that section will be measured using the hospital's SYNAPS system. The results will be recorded in cm2.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
İstanbul, Turkey, 34173
- Istanbul Physical Medicine Rehabilitation Training & Research Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- No chronic disease
- Being under 18 years of age
- Being Turkish
- Determining that an abdominal CT was performed in the hospital records
Exclusion Criteria:
- Patients with malignancy or known chronic disease
- Patients with mental health problems
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
L3-L4 LEVEL: Psoas muscle area
Time Frame: 1 interview day
|
The Psoas muscle area at the L3-L4 vertebra level in the patients' abdominal computed tomography will be measured.
|
1 interview day
|
|
L3-L4 LEVEL:Paraspinal muscle area
Time Frame: 1 interview day
|
The Paraspinal muscle area at the L3-L4 vertebra level in the patients' abdominal computed tomography will be measured.
|
1 interview day
|
|
L3-L4 LEVEL: Abdominal muscle area,
Time Frame: 1 interview day
|
The Abdominal muscle area at the L3-L4 vertebra level in the patients' abdominal computed tomography will be measured.
|
1 interview day
|
|
L4-L5 LEVEL: Psoas muscle area
Time Frame: 1 interview day
|
The Psoas muscle area at the L4-L5 vertebra level in the patients' abdominal computed tomography will be measured.
|
1 interview day
|
|
L4-L5 LEVEL: Paraspinal muscle area
Time Frame: 1 interview day
|
The Paraspinal muscle area at the L4-L5 vertebra level in the patients' abdominal computed tomography will be measured.
|
1 interview day
|
|
L4-L5 LEVEL: Abdominal muscle area,
Time Frame: 1 interview day
|
The Abdominal muscle area at the L3-L4 vertebra level in the patients' abdominal computed tomography will be measured.
|
1 interview day
|
Collaborators and Investigators
Investigators
- Study Chair: TUGBA AYDIN, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Principal Investigator: EDA CINGOZ, ISTANBUL BAĞCILAR TRAINING AND RESEARCH HOSPITAL RADIOLOGY UNIT
Publications and helpful links
General Publications
- Kudo W, Terui K, Hattori S, Takenouchi A, Komatsu S, Oita S, Sato Y, Hishiki T. Establishment and validation of reference values for abdominal skeletal muscle compartments in children. Clin Nutr. 2023 May;42(5):653-660. doi: 10.1016/j.clnu.2023.02.022. Epub 2023 Mar 2.
- Harbaugh CM, Zhang P, Henderson B, Derstine BA, Holcombe SA, Wang SC, Kohoyda-Inglis C, Ehrlich PF. Personalized medicine: Enhancing our understanding of pediatric growth with analytic morphomics. J Pediatr Surg. 2017 May;52(5):837-842. doi: 10.1016/j.jpedsurg.2017.01.030. Epub 2017 Jan 29.
- Metzger GA, Sebastiao YV, Carsel AC, Nishimura L, Fisher JG, Deans KJ, Minneci PC. Establishing Reference Values for Lean Muscle Mass in the Pediatric Patient. J Pediatr Gastroenterol Nutr. 2021 Feb 1;72(2):316-323. doi: 10.1097/MPG.0000000000002958.
- Lurz E, Patel H, Lebovic G, Quammie C, Woolfson JP, Perez M, Ricciuto A, Wales PW, Kamath BM, Chavhan GB, Juni P, Ng VL. Paediatric reference values for total psoas muscle area. J Cachexia Sarcopenia Muscle. 2020 Apr;11(2):405-414. doi: 10.1002/jcsm.12514. Epub 2020 Jan 9.
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 (Estimated)
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
- IstPMR-ct-mscl-chld
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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