Clinical trial NCT03559296: Reliability of Subcutaneous Echogenicity (SEG) Grade and Subcutaneous Echo-free Space (SEFS) Grade
Official title: The Inter- and Intra-rater Reliability of Subcutaneous Echogenicity (SEG) Grade and Subcutaneous Echo-free Space (SEFS) Grade in Postmastectomy Lymphedema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmastectomy Lymphedema Syndrome
Keywords: imaging
assessment
edema
dermis
postmastectomy Lymphedema
reliability
ultrasound
grade
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with postmastectomy lymphedema aged 18-65 years old

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: International Society of Lymphology (ISL) stage by rater 1
timeFrame: Day 0
measure: International Society of Lymphology (ISL) stage by rater 1
timeFrame: Day 3
measure: International Society of Lymphology (ISL) stage by rater 2
timeFrame: Day 0
Secondary outcomes:
measure: MCP joint level affected arm
timeFrame: Day 0
measure: MCP joint level unaffected arm
timeFrame: Day 0
measure: wrist joint level affected arm
timeFrame: Day 0
measure: wrist joint level unaffected arm
timeFrame: Day 0
measure: 15 cm below the elbow joint point affected arm
timeFrame: Day 0
measure: 15 cm below the elbow joint point unaffected arm
timeFrame: Day 0
measure: elbow joint point affected arm
timeFrame: Day 0
measure: elbow joint point unaffected arm
timeFrame: Day 0
measure: 15 cm above the elbow joint point affected arm
timeFrame: Day 0
measure: 15 cm above the elbow joint point unaffected arm
timeFrame: Day 0
measure: Affected extremity volume (mL)
timeFrame: Day 0
measure: Unaffected extremity volume (mL)
timeFrame: Day 0
measure: Subcutaneous echogenicity (SEG) grade by rater 1
timeFrame: Day 0
measure: Subcutaneous echogenicity (SEG) grade by rater 1
timeFrame: Day 3
measure: Subcutaneous echogenicity (SEG) grade by rater 2
timeFrame: Day 0
measure: Subcutaneous echo-free space (SEFS) grade by rater 1
timeFrame: Day 0
measure: Subcutaneous echo-free space (SEFS) grade by rater 1
timeFrame: Day 3
measure: Subcutaneous echo-free space (SEFS) grade by rater 2
timeFrame: Day 0
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Marmara University
name: İlker Yagci, Prof, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University
name: Esra Giray, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.