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临床试验/NCT04588493
NCT04588493已完成不适用

Human Adjuvant Disease as a Cause of Secondary Lower Extremity Lymphedema

Hospital Angeles del Pedregal1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2017年3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
5
试验地点
1
主要终点
Transport Index

研究概览

简要总结

This observational, descriptive, retrospective study the clinical and imaging findings of 10 lower legs of 5 patients with previous history of injection of modeling substances for cosmetic purposes at buttocks and hips ande developed lower limb edema. Lower limb lymphedema index and lymphoscintigraphy findings were evaluated and reported.

详细描述

Lymphoscintigraphy findings were reported with the Transport index (TI), were any value over 5 will represent abnormalities in lymphatic function.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 18 years old
  • History of injection of modelling substances for cosmetic purposes
  • History of lower limb edema

排除标准

  • History of primary lower limb lymphedema
  • Reject to participate
  • Confirmed other causes of edema

结局指标

主要结局

Transport Index

时间窗: 4 months

Transport index in each pelvic limb: transport kinematics, distribution pattern, index time for the appearance of regional lymph nodes, number and collection of colloids in lymph nodes and presence and quality of the colloid uptake by the lymphatic vessels. Summation of these five components resulted in the transport index, which could range from 0 to 45 points; less than 5 means a normal study, higher scores represent abnormal or pathological results

次要结局

  • Lower extremity lymphedema index(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

javier lopez

Principal investigator, Plastic and reconstructive surgeon staff, MBA, FACS

Hospital Angeles del Pedregal

研究点 (1)

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