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临床试验/NCT03559296
NCT03559296已完成不适用

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

Marmara University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
International Society of Lymphology (ISL) stage by rater 1

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Patients with unilateral postmastectomy lymphedema

排除标准

  • •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

结局指标

主要结局

International Society of Lymphology (ISL) stage by rater 1

时间窗: Day 3

stage of the clinical severity of lymphedema

International Society of Lymphology (ISL) stage by rater 2

时间窗: Day 0

stage of the clinical severity of lymphedema

次要结局

  • elbow joint point affected arm(Day 0)
  • 15 cm above the elbow joint point affected arm(Day 0)
  • 15 cm above the elbow joint point unaffected arm(Day 0)
  • MCP joint level unaffected arm(Day 0)
  • 15 cm below the elbow joint point unaffected arm(Day 0)
  • Affected extremity volume (mL)(Day 0)
  • Unaffected extremity volume (mL)(Day 0)
  • Subcutaneous echo-free space (SEFS) grade by rater 1(Day 3)
  • MCP joint level affected 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)
  • elbow joint point unaffected arm(Day 0)
  • Subcutaneous echogenicity (SEG) grade by rater 1(Day 3)
  • Subcutaneous echogenicity (SEG) grade by rater 2(Day 0)
  • Subcutaneous echo-free space (SEFS) grade by rater 2(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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