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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06121791
Other study ID # IstPMR-ct-mscl-chld
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 25, 2023
Est. completion date March 1, 2024

Study information

Verified date December 2023
Source Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Contact TUGBA AYDIN, ASSOC.PROF
Phone +905324622162
Email drtugbaaydin@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study was to establish reference values for three compartments of the abdominal skeletal muscle area (psoas muscle area, paraspinal muscle area, and total skeletal muscle area) obtained from cross-sectional Computed tomography images in Turkish Children


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 5000
Est. completion date March 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers
Gender All
Age group N/A to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Normal values of abdominal level muscle areas of Turkish children
age, sex, L3-L4 LEVEL: Psoas muscle area, Paraspinal muscle area, Abdominal muscle area, L4-L5 LEVEL: Psoas muscle area, Paraspinal muscle area, Abdominal muscle area

Locations

Country Name City State
Turkey Istanbul Physical Medicine Rehabilitation Training & Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary L3-L4 LEVEL: Psoas muscle area The Psoas muscle area at the L3-L4 vertebra level in the patients' abdominal computed tomography will be measured. 1 interview day
Primary L3-L4 LEVEL:Paraspinal muscle area The Paraspinal muscle area at the L3-L4 vertebra level in the patients' abdominal computed tomography will be measured. 1 interview day
Primary L3-L4 LEVEL: Abdominal muscle area, The Abdominal muscle area at the L3-L4 vertebra level in the patients' abdominal computed tomography will be measured. 1 interview day
Primary L4-L5 LEVEL: Psoas muscle area The Psoas muscle area at the L4-L5 vertebra level in the patients' abdominal computed tomography will be measured. 1 interview day
Primary L4-L5 LEVEL: Paraspinal muscle area The Paraspinal muscle area at the L4-L5 vertebra level in the patients' abdominal computed tomography will be measured. 1 interview day
Primary L4-L5 LEVEL: Abdominal muscle area, The Abdominal muscle area at the L3-L4 vertebra level in the patients' abdominal computed tomography will be measured. 1 interview day
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