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临床试验/NCT05970068
NCT05970068尚未招募不适用

Implantation of Hydrophobic Tubes for Edema Fluid Drainage in Obstructive Lymphedema of Limbs - a Randomized Clinical Trial

Universidade do Porto2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
2
主要终点
Lower limb circumference in cm

研究概览

简要总结

Lymphedema is a chronic condition causing fluid buildup in affected limbs. Traditional treatments often fall short, but subcutaneous implantation of hydrophobic silicone tubes shows promise, creating artificial drainage pathways. This approach proved effective in managing obstructive lymphedema in lower limbs. Further research is needed to validate its efficacy and explore long-term outcomes.

详细描述

Lymphedema is a chronic condition that affects the lymphatic system and accumulates protein-rich fluid in the interstitial spaces of the affected limb. The condition can occur after surgery, trauma, radiation therapy, or infection and can cause significant physical, functional, and psychosocial impairment. The chronic swelling and fibrosis of the affected limb can lead to difficulty with daily activities, decreased mobility, reduced quality of life, and increased susceptibility to infections (1).

Currently, the management of lymphedema involves both conservative and surgical approaches. Conservative treatment includes complex decongestive therapy, which combines manual lymphatic drainage, compression therapy, exercise, and skincare (reference here). While this approach can be effective, it requires long-term commitment and compliance from patients, which can be challenging (reference here). Surgical approaches, such as lymphaticovenular anastomosis or vascularized lymph node transfer, are reserved for patients with mild to severe or refractory lymphedema with moderate results (2).

Liposuction has been used as a treatment for lower limb lymphedema. The traditional treatment of lymphedema includes compression garments, exercise, and manual lymphatic drainage, but these methods are not very effective.

In advanced cases of lymphedema, where all main lymphatics vessels are obstructed, one possible solution may be to create artificial pathways for edema fluid to flow away from the obstructed regions. This can be achieved through the subcutaneous implantation of silicone tubes, a novel method for draining edema fluid in obstructive lymphedema of limbs (3).

In the lower limbs, the tubes are placed from the leg to the lumbar or hypogastric region, creating channels for fluid to flow away from the obstructed areas to the non-obstructed regions, where absorption can take place.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Lower limb lymphedema (Grade II-IV)
  • Total occlusion at lymphoscintigraphy
  • Patients treated at Centro Hospitalar Universitário de São João by the same surgical team
  • Age >18 years old;
  • Lymphedema praecox
  • Lower limb perimeter >15% superior to contralateral limb

排除标准

  • Secondary lymphedema
  • Congenital lymphedema (Milroy, Meige, Klinefelter, Noonan, and Turner syndromes)
  • Acute infection of the limb
  • Chronic venous insufficiency
  • Neoplasic disease

结局指标

主要结局

Lower limb circumference in cm

时间窗: Preoperative, six months, one year, second year

Lower limb circumference in cm - ankle, calf 15 cm below the knee; knee; thigh 15 cm above the knee

次要结局

  • Lymphoscintigraphy(preoperative, one year (only in the intervention group))
  • PROMS - Lymphedema quality of life(preoperative, six months, one year, two years)
  • PROMS - SF 36(preoperative, six months, one year, two years)

研究者

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

João Rocha Neves

MD, MPH, PHD, FEBVS

Universidade do Porto

研究点 (2)

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