跳至主要内容
临床试验/NCT02494115
NCT02494115已完成不适用

Comfort Subcutaneous Drainage: a Descriptive Study Among Palliative Care Cancer Patients Presenting Severe Refractory Lower Limbs Lymphedema

Centre Hospitalier Universitaire de Nice6 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年1月6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
24
试验地点
6
主要终点
evolution of the patient's discomfort due to his oedemas

研究概览

简要总结

Physical embarrassment, pain and psychological impact linked to the body image distortion are often associated to these lymphedemas. Investigators decided to study new therapeutic method because of major discomfort due to these oedemas and doctors' difficulty to manage them.

Subcutaneous drainage also called lymphocentesis seems to be an interesting technique. This local treatment consists in inserting in lower limbs several catheters draining into enclosed bags in order to evacuate lymph fluid and to lower local pressure.

Very few studies have been published concerning this technique and are presenting only a small number of cases. They cannot allow clear conclusions of this technique's efficiency but show encouraging results.

Investigators want to collect more data on this technique using a larger number of subjects in order to evaluate subcutaneous drainage effects on the comfort of palliative care cancer patients presenting lower limbs lymphedema. Investigators will consider as lymphedema, oedemas with no renal or cardiovascular identified cause and excluding anasarca.

详细描述

Lower limbs lymphedemas are often reported in advanced palliative phase cancer patients. These oedemas have multiple causes and are complicated to be taken care of. Actual available treatments such as physiotherapist massage and compression stockings, are often lacking efficiency and are not adapted for these patients.

Physical embarrassment, pain and psychological impact linked to the body image distortion are often associated to these lymphedemas. Investigators decided to study new therapeutic method because of major discomfort due to these oedemas and doctors' difficulty to manage them.

Subcutaneous drainage also called lymphocentesis seems to be an interesting technique. This local treatment consists in inserting in lower limbs several catheters draining into enclosed bags in order to evacuate lymph fluid and to lower local pressure.

Very few studies have been published concerning this technique and are presenting only a small number of cases. They cannot allow clear conclusions of this technique's efficiency but show encouraging results.

Investigators want to collect more data on this technique using a larger number of subjects in order to evaluate subcutaneous drainage effects on the comfort of palliative care cancer patients presenting lower limbs lymphedema. Investigators will consider as lymphedema, oedemas with no renal or cardiovascular identified cause and excluding anasarca.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Cancer patients
  • Palliative care patients according to the SFAP (French Palliative care society) definition
  • Patient taken care of in one of the palliative care structures implied in this project (palliative care unit, palliative care field team, hospital at home, palliative care day hospital)
  • Patients presenting lower limb lymphedema resistant to traditional treatments or for whom these treatments are not adapted
  • Lymphedema being a source of discomfort for the patient asking for relief
  • Patient wishing a new treatment for lymphedema
  • Patients with full cognitive capacities evaluated by the practitioner in charge of him
  • Patients available during the study

排除标准

  • Lost-of-sight or transferred to another hospital subjects
  • Subjects wishing to end their participation before study ending

结局指标

主要结局

evolution of the patient's discomfort due to his oedemas

时间窗: on the 3rd day after lymphcentesis

It will be measured with a numeric scale from 0 no discomfort to 10 maximal discomfort.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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