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

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

Detailed Description
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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.

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

Conditions
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Postmastectomy Lymphedema Syndrome

Intervention / Treatment
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* Diagnostic Test: Ultrasonographic assessment of postmastectomy lymphedema


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MCP joint level affected arm | The circumferential measurement of affected arm at the metacarpophalangeal joints (MCP) | Day 0 | 
| MCP joint level unaffected arm | The circumferential measurement of affected arm at the MCP joints | Day 0 | 
| wrist joint level affected arm | The circumferential measurement of affected arm at wrist joint | Day 0 | 
| wrist joint level unaffected arm | The circumferential measurement of affected arm at wrist joint | Day 0 | 
| 15 cm below the elbow joint point affected arm | The circumferential measurement of affected arm at 15 cm below the elbow joint point | Day 0 | 
| 15 cm below the elbow joint point unaffected arm | The circumferential measurement of affected arm at 15 cm below the elbow joint point | Day 0 | 
| elbow joint point affected arm | The circumferential measurement of affected arm at the elbow joint point | Day 0 | 
| elbow joint point unaffected arm | The circumferential measurement of unaffected arm at the elbow joint point | Day 0 | 
| 15 cm above the elbow joint point affected arm | The circumferential measurement of affected arm at 15 cm above the elbow joint point | Day 0 | 
| 15 cm above the elbow joint point unaffected arm | The circumferential measurement of affected arm at 15 cm above the elbow joint point | Day 0 | 
| Affected extremity volume (mL) | 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. | Day 0 | 
| Unaffected extremity volume (mL) | 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. | Day 0 | 
| Subcutaneous echogenicity (SEG) grade by rater 1 | 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 | Day 0 | 
| Subcutaneous echogenicity (SEG) grade by rater 1 | 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 | Day 3 | 
| Subcutaneous echogenicity (SEG) grade by rater 2 | 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 | Day 0 | 
| Subcutaneous echo-free space (SEFS) grade by rater 1 | 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. | Day 0 | 
| Subcutaneous echo-free space (SEFS) grade by rater 1 | 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. | Day 3 | 
| Subcutaneous echo-free space (SEFS) grade by rater 2 | 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. | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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imaging, assessment, edema, dermis, postmastectomy Lymphedema, reliability, ultrasound, grade