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NCT Number: NCT03559296

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

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

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Key information

Conditions

Postmastectomy Lymphedema Syndrome Breast Cancer Lymphedema Edema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34899, Turkey (Türkiye)

About this study

The clinical severity of lymphedema in an extremity is generally graded according to the International Society of Lymphology (ISL) stage. Stage 0 which refers to a latent or subclinical condition where swelling is not evident despite impaired lymph transport. It may exist months or years before overt edema occurs (Stages I-III). Stage I represents an early accumulation of fluid relatively high in protein content (e.g., in comparison with "venous" edema) and subsides with limb elevation. Pitting may occur. Stage II signifies that limb elevation alone rarely reduces tissue swelling and pitting is manifest. Late in Stage II, the limb may or may not pit as tissue fibrosis supervenes. Stage III encompasses lymphostatic elephantiasis where pitting is absent and trophic skin changes such as acanthosis, fat deposits, and warty overgrowths develop. Within each Stage, severity based on volume difference can be assessed as minimal (<20% increase) in limb volume, moderate (20-40% increase), or severe (>40% increase).

Because the ISL stage mainly consists of findings achieved by physical examinations and represents the most severely affected arm, it is subjective and may not reflect the distribution and mode of progression of the disease. The characteristic skin and subcutaneous tissue changes in extremities with chronic lymphedema are caused by changes in the extracellular matrix, such as connective tissue hypertrophy, fat accumulation resulting from both fat hypertrophy and an increased number of adipocytes, and interstitial protein-rich fluid accumulation. Ultrasound has been used to assess and diagnose lymphedema related changes. Subcutaneous echogenicity (SEG) and subcutaneous echo-free space (SEFS) grade systems for postmastectomy lymphedema are developed in order to grade lymphedema objectively and to delineate the disease status more clearly. However, the reliability of SEG and SEFS has not been evaluated. The aims of this study is to determine the inter- and intra-rater reliability of SEG and SEFS grade systems for postmastectomy lymphedema. Two physiatrist (one ten-year-experienced and one five-year-experienced in musculoskeletal ultrasonography) independently and alternately will assess the subjects once for each assessment. Three days later after the initial examination, one of the physiatrists reassessed the patients. The inter- and intra-rater reliability will be determined using kappa.

Who can participate

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

Inclusion criteria

  • Patients with unilateral postmastectomy lymphedema

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

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

    Time frame: Day 0

    stage of the clinical severity of lymphedema

  2. International Society of Lymphology (ISL) stage by rater 1

    Time frame: Day 3

    stage of the clinical severity of lymphedema

  3. International Society of Lymphology (ISL) stage by rater 2

    Time frame: Day 0

    stage of the clinical severity of lymphedema

Secondary outcomes

  1. MCP joint level affected arm

    Time frame: Day 0

    The circumferential measurement of affected arm at the metacarpophalangeal joints (MCP)

  2. MCP joint level unaffected arm

    Time frame: Day 0

    The circumferential measurement of affected arm at the MCP joints

  3. wrist joint level affected arm

    Time frame: Day 0

    The circumferential measurement of affected arm at wrist joint

  4. wrist joint level unaffected arm

    Time frame: Day 0

    The circumferential measurement of affected arm at wrist joint

  5. 15 cm below the elbow joint point affected arm

    Time frame: Day 0

    The circumferential measurement of affected arm at 15 cm below the elbow joint point

  6. 15 cm below the elbow joint point unaffected arm

    Time frame: Day 0

    The circumferential measurement of affected arm at 15 cm below the elbow joint point

  7. elbow joint point affected arm

    Time frame: Day 0

    The circumferential measurement of affected arm at the elbow joint point

  8. elbow joint point unaffected arm

    Time frame: Day 0

    The circumferential measurement of unaffected arm at the elbow joint point

  9. 15 cm above the elbow joint point affected arm

    Time frame: Day 0

    The circumferential measurement of affected arm at 15 cm above the elbow joint point

  10. 15 cm above the elbow joint point unaffected arm

    Time frame: Day 0

    The circumferential measurement of affected arm at 15 cm above the elbow joint point

  11. Affected extremity volume (mL)

    Time frame: Day 0

    Lymphedema of the limbs were assessed by a single physiotherapist using the circumferential and volumetric methods before and after the treatment protocol. The circumferential upper limb measurements were carried out with the arm abducted at 30°, starting at the level of the carpometacarpal joint, every 5 cm proximal to this point along both limbs. Then, a computer program (limb volumes professional version 5.0) was used to convert these values into limb volumes in milliliters.

  12. Unaffected extremity volume (mL)

    Time frame: Day 0

    Lymphedema of the limbs were assessed by a single physiotherapist using the circumferential and volumetric methods before and after the treatment protocol. The circumferential upper limb measurements were carried out with the arm abducted at 30°, starting at the level of the carpometacarpal joint, every 5 cm proximal to this point along both limbs. Then, a computer program (limb volumes professional version 5.0) was used to convert these values into limb volumes in milliliters.

  13. Subcutaneous echogenicity (SEG) grade by rater 1

    Time frame: Day 0

    Grade 0: No increase in echogenicity in the subcutaneous layer. Namely, the subcutaneous fat layer is observed as black. Grade 1: Diffuse increase in echogenicity, but identifiable horizontal or obliquely oriented echogenic lines caused by connective tissue bundles. Grade 2: Diffuse increase in echogenicity. Echogenic lines are not identifiable

  14. Subcutaneous echogenicity (SEG) grade by rater 1

    Time frame: Day 3

    Grade 0: No increase in echogenicity in the subcutaneous layer. Namely, the subcutaneous fat layer is observed as black. Grade 1: Diffuse increase in echogenicity, but identifiable horizontal or obliquely oriented echogenic lines caused by connective tissue bundles. Grade 2: Diffuse increase in echogenicity. Echogenic lines are not identifiable

  15. Subcutaneous echogenicity (SEG) grade by rater 2

    Time frame: Day 0

    Grade 0: No increase in echogenicity in the subcutaneous layer. Namely, the subcutaneous fat layer is observed as black. Grade 1: Diffuse increase in echogenicity, but identifiable horizontal or obliquely oriented echogenic lines caused by connective tissue bundles. Grade 2: Diffuse increase in echogenicity. Echogenic lines are not identifiable

  16. Subcutaneous echo-free space (SEFS) grade by rater 1

    Time frame: Day 0

    Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (≥45 degrees to the skin) SEFS bridging the horizontally oriented SEFSs.

  17. Subcutaneous echo-free space (SEFS) grade by rater 1

    Time frame: Day 3

    Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (≥45 degrees to the skin) SEFS bridging the horizontally oriented SEFSs.

  18. Subcutaneous echo-free space (SEFS) grade by rater 2

    Time frame: Day 0

    Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (≥45 degrees to the skin) SEFS bridging the horizontally oriented SEFSs.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

The Inter- and Intra-rater Reliability of Subcutaneous Echogenicity (SEG) Grade and Subcutaneous Echo-free Space (SEFS) Grade in Postmastectomy Lymphedema

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 18, 2018
Registry last updated
Aug 23, 2018

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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