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Completed

NCT Number: NCT06354348

Practical Ultrasonographic Detection of Sarcopenia in Patients With Long-term Gastrectomy

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.

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Diagnosis of sarcopenia The ISarcoPRM algorithm was used whereby 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

USG, Grip strength, Chair stand test (CST)

Diagnostic Test

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.

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2024
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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