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

Postmastectomy Lymphedema Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03559296
• Other study ID #: 09.2018.466
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: August 13, 2018

Study information

• Verified date: August 2018
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 13, 2018
• Est. primary completion date: August 13, 2018
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients with unilateral postmastectomy lymphedema

Exclusion Criteria:

1. Bilateral lymphedema

2. 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

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Lymphedema
• Postmastectomy Lymphedema Syndrome
• Postoperative Complications

Intervention

Diagnostic Test:
• Ultrasonographic assessment of postmastectomy lymphedema
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

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine Department of Physical Medicine and Rehabilitation	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Society of Lymphology (ISL) stage by rater 1	stage of the clinical severity of lymphedema	Day 0
Primary	International Society of Lymphology (ISL) stage by rater 1	stage of the clinical severity of lymphedema	Day 3
Primary	International Society of Lymphology (ISL) stage by rater 2	stage of the clinical severity of lymphedema	Day 0
Secondary	MCP joint level affected arm	The circumferential measurement of affected arm at the metacarpophalangeal joints (MCP)	Day 0
Secondary	MCP joint level unaffected arm	The circumferential measurement of affected arm at the MCP joints	Day 0
Secondary	wrist joint level affected arm	The circumferential measurement of affected arm at wrist joint	Day 0
Secondary	wrist joint level unaffected arm	The circumferential measurement of affected arm at wrist joint	Day 0
Secondary	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
Secondary	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
Secondary	elbow joint point affected arm	The circumferential measurement of affected arm at the elbow joint point	Day 0
Secondary	elbow joint point unaffected arm	The circumferential measurement of unaffected arm at the elbow joint point	Day 0
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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