NCT06354348

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

March 30, 2024

Last Update Submit

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

EXPERIMENTAL

Patients with esophagojejunostomy on endoscopic evaluation were considered as total gastrectomy.

Diagnostic Test: USG, Grip strength, Chair stand test (CST)

Distal gastrectomy

EXPERIMENTAL

Patients with resected mid-corpus with preserved corpus, fundus and cardia and gastrojejunostomy were considered as distal gastrectomy.

Diagnostic Test: USG, Grip strength, Chair stand test (CST)

No gastrectomy status

EXPERIMENTAL

Has not undergone a gastrectomy operation

Diagnostic Test: USG, Grip strength, Chair stand test (CST)

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.

Distal gastrectomyNo gastrectomy statusTotal gastrectomy

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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: 34121127BACKGROUND
  • Takahashi 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: 31509590BACKGROUND
  • Okamoto 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: 34837102BACKGROUND
  • Kara 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

Sarcopenia

Interventions

Hand Strength

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Muscle StrengthPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

Locations