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

NCT ID: NCT06354348

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-06

Study Completion Date

2024-03-30

Brief Summary

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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

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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).

Conditions

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Sarcopenia Gastrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Total gastrectomy

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

Group Type EXPERIMENTAL

USG, Grip strength, Chair stand test (CST)

Intervention Type 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.

Distal gastrectomy

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

Group Type EXPERIMENTAL

USG, Grip strength, Chair stand test (CST)

Intervention Type 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.

No gastrectomy status

Has not undergone a gastrectomy operation

Group Type EXPERIMENTAL

USG, Grip strength, Chair stand test (CST)

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Who agreed to participate in the study
* Total or subtotal gastrectomy at least 1 year ago

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Semih Sezer

clinic physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 34121127 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31509590 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34837102 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32941253 (View on PubMed)

Other Identifiers

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GastrectomyUSG

Identifier Type: -

Identifier Source: org_study_id

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