Practical Ultrasonographic Detection of Sarcopenia in Patients With Long-term Gastrectomy
1 other identifier
interventional
90
1 country
1
Brief Summary
The investigators aimed to evaluate long-term sarcopenia in patients with total and distal gastrectomy by measuring the anterior thigh muscle with USG, which is a more specific and easy method.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 6, 2023
CompletedFirst Submitted
Initial submission to the registry
March 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedFirst Posted
Study publicly available on registry
April 9, 2024
CompletedApril 9, 2024
April 1, 2024
4 months
March 30, 2024
April 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Sarcopenia (Sonographic thigh adjustment ratio (STAR) was calculated by dividing the anterior thigh muscle thickness (mm) by BMI )
The diagnosis of sarcopenia was established if low muscle mass (i.e. STAR values \<1.4 for males and \<1.0 for females) was combined with low grip strength (\<32 kg (males) and \<19 kg (females)) and/or increased CST time (≥12 sec)
through study completion, an average of 4 months
Study Arms (3)
Total gastrectomy
EXPERIMENTALPatients with esophagojejunostomy on endoscopic evaluation were considered as total gastrectomy.
Distal gastrectomy
EXPERIMENTALPatients with resected mid-corpus with preserved corpus, fundus and cardia and gastrojejunostomy were considered as distal gastrectomy.
No gastrectomy status
EXPERIMENTALHas not undergone a gastrectomy operation
Interventions
Anterior thigh muscle thickness was measured with USG Grip strength was measured with an electronic hand dynamometer Chair stand test (CST) was performed while participants were asked to stand up and sit down from a chair - without arm rest, for five times as quick as possible, with their arms crossed over their chests.
Eligibility Criteria
You may qualify if:
- Who agreed to participate in the study
- Total or subtotal gastrectomy at least 1 year ago
You may not qualify if:
- Rheumatic/neurological diseases
- Any organ failure,
- Limitation of mobility
- History of major orthopedic surgery,
- Chemotherapy programs
- Gastric carcinoma recurrence
- Parkinson's disease, previous stroke, cerebellar diseases, multiple sclerosis
- Major depression
- Those who use any assistive device for walking
- People with severe knee, hip and hand osteoarthritis
- Active malignancies (currently or within the last 1 year receiving radiotherapy/chemotherapy
- Severe chronic obstructive pulmonary disease
- Visual impairment and vestibular disorders
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, Turkey (Türkiye)
Related Publications (4)
Kara M, Kaymak B, Frontera W, Ata AM, Ricci V, Ekiz T, Chang KV, Han DS, Michail X, Quittan M, Lim JY, Bean JF, Franchignoni F, Ozcakar L. Diagnosing sarcopenia: Functional perspectives and a new algorithm from the ISarcoPRM. J Rehabil Med. 2021 Jun 21;53(6):jrm00209. doi: 10.2340/16501977-2851.
PMID: 34121127BACKGROUNDTakahashi S, Shimizu S, Nagai S, Watanabe H, Nishitani Y, Kurisu Y. Characteristics of sarcopenia after distal gastrectomy in elderly patients. PLoS One. 2019 Sep 11;14(9):e0222412. doi: 10.1371/journal.pone.0222412. eCollection 2019.
PMID: 31509590BACKGROUNDOkamoto A, Aikou S, Iwata R, Oya S, Kawasaki K, Okumura Y, Yagi K, Yamashita H, Nomura S, Seto Y. The type of gastrectomy affects skeletal muscle loss and the long-term outcomes of elderly patients with gastric cancer: a retrospective study using computed tomography images. Surg Today. 2022 May;52(5):812-821. doi: 10.1007/s00595-021-02414-2. Epub 2021 Nov 26.
PMID: 34837102BACKGROUNDKara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.
PMID: 32941253BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinic physician
Study Record Dates
First Submitted
March 30, 2024
First Posted
April 9, 2024
Study Start
December 6, 2023
Primary Completion
March 30, 2024
Study Completion
March 30, 2024
Last Updated
April 9, 2024
Record last verified: 2024-04