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Clinical Trials/NCT06354348
NCT06354348CompletedNot Applicable

Practical Ultrasonographic Detection of Sarcopenia in Patients With Long-term Gastrectomy: A Cross-sectional Case-control Study

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital2 sites in 2 countries90 target enrollmentStarted: December 6, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
90
Locations
2
Primary Endpoint
Sarcopenia (Sonographic thigh adjustment ratio (STAR) was calculated by dividing the anterior thigh muscle thickness (mm) by BMI )

Study Overview

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.

Detailed Description

Sarcopenia was found to be significantly increased in patients who underwent total, proximal and distal gastrectomy compared to those who did not undergo gastrectomy in the long term.

To date, very few studies have investigated the development of sarcopenia in the long term after gastrectomy. In these studies, sarcopenia was usually assessed using BIA and DEXA. Muscle thickness measured by ultrasound has high sensitivity and specificity in determining regional muscle mass.

Patients who underwent total(n=20) and subtotal gastrectomy(n=35) and patients who did not undergo gastrectomy(n=35) were included in the study.

Ultrasonographic measurements Anterior thigh muscle thickness of the dominant side was measured at the mid-point between the anterior superior iliac spine and the upper border of the patella. Transverse measurements were obtained between the outer fascia of rectus femoris muscle and the periosteum of femur. Sonographic thigh adjustment ratio (STAR) was calculated by dividing the anterior thigh muscle thickness (mm) by BMI.

Functional evaluations Grip strength was measured with an electronic hand dynamometer. Three repeat measurements were performed from the dominant side and the maximum value was taken for the analyses. 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. Three measurements were performed and median values were taken for the analyses.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
45 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Who agreed to participate in the study
  • Total or subtotal gastrectomy at least 1 year ago
  • The control group consisted of patients without gastrectomy with similar

Exclusion Criteria

  • as the patient group
  • Exclusion Criteria:
  • 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

Outcomes

Primary Outcomes

Sarcopenia (Sonographic thigh adjustment ratio (STAR) was calculated by dividing the anterior thigh muscle thickness (mm) by BMI )

Time Frame: through study completion, an average of 4 months

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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Semih Sezer

clinic physician

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Study Sites (2)

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