Reliability of Subcutaneous Echogenicity (SEG) Grade and Subcutaneous Echo-free Space (SEFS) Grade

NCT03559296 | Completed

• 1 other identifier: 09.2018.466
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study is to determine the inter- and intra-rater reliability of SEG and SEFS grade systems for postmastectomy lymphedema.

Conditions

Postmastectomy Lymphedema Syndrome

Keywords

imaging; assessment; edema; dermis; postmastectomy Lymphedema; reliability; ultrasound; grade

Outcome Measures

Primary Outcomes (3)

• International Society of Lymphology (ISL) stage by rater 1

  stage of the clinical severity of lymphedema

  Day 0

• International Society of Lymphology (ISL) stage by rater 1

  stage of the clinical severity of lymphedema

  Day 3

• International Society of Lymphology (ISL) stage by rater 2

  stage of the clinical severity of lymphedema

  Day 0

Secondary Outcomes (18)

• MCP joint level affected arm

  Day 0

• MCP joint level unaffected arm

  Day 0

• wrist joint level affected arm

  Day 0

• wrist joint level unaffected arm

  Day 0

• 15 cm below the elbow joint point affected arm

  Day 0

Study Arms (1)

Study Group

patients with postmastectomy lymphedema who will undergo ultrasonographic assessment of postmastectomy lymphedema and circumferential tape measurement of arm

Diagnostic Test: Ultrasonographic assessment of postmastectomy lymphedema

Interventions

Ultrasonographic assessment of postmastectomy lymphedema DIAGNOSTIC_TEST

Qualitative assessment of postmastectomy lymphedema via ultrasound (Subcutaneous echogenicity (SEG) and subcutaneous echo-free space (SEFS) grade systems for postmastectomy lymphedema) and circumferential tape measures ( The circumferential measurement of affected arm at MCP joint, wrist joint, 15 below elbow joint, elbow joint 15cm above elbow point) to assess upper extremity volume

Study Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Women with postmastectomy lymphedema
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women with postmastectomy lymphedema aged 18-65 years old

You may qualify if:

• \. Patients with unilateral postmastectomy lymphedema

You may not qualify if:

• Bilateral lymphedema
• The patients who had known systemic edemagenic conditions (e.g., cardiac/hepatic/renal failure, terminal cancer, on chemotherapy), and/or with cancer recurrence were excluded

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (1)

• Giray E, Yagci I. Interrater and Intrarater Reliability of Subcutaneous Echogenicity Grade and Subcutaneous Echo-Free Space Grade in Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2019 Oct;17(5):518-524. doi: 10.1089/lrb.2018.0053. Epub 2018 Dec 20.

  PMID: 30570358 DERIVED

MeSH Terms

Conditions

Edema; Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes

Study Officials

• İlker Yagci, Prof, Msc

  Marmara University

  PRINCIPAL INVESTIGATOR

• Esra Giray, MD

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 18, 2018
• Study Start: July 1, 2018
• Primary Completion: August 13, 2018
• Study Completion: August 13, 2018
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)