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

April 5, 2024 updated by: Semih Sezer, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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).

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Total gastrectomy
Patients with esophagojejunostomy on endoscopic evaluation were considered as total gastrectomy.
Diagnostic test: USG, Grip strength, Chair stand test (CST)
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.
Experimental: Distal gastrectomy
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)
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.
Experimental: No gastrectomy status
Has not undergone a gastrectomy operation
Diagnostic test: USG, Grip strength, Chair stand test (CST)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
through study completion, an average of 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2023

Primary Completion (Actual)

March 30, 2024

Study Completion (Actual)

March 30, 2024

Study Registration Dates

First Submitted

March 30, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GastrectomyUSG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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