跳至主要内容
临床试验/CTRI/2008/091/000249
CTRI/2008/091/000249未知3 期

To study the influence of prophylactic application of the class 2 upper limb stockings in carcinoma breast patients in reducing the incidence of Breast cancer related lymph edema [BCRL]

fluid research -institute1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 待定

试验速览

阶段
3 期
发起方
入组人数
80
试验地点
1
主要终点
Percentage of reduction in arm volume in the study group will be analyzed which will indirectly give the reduction in the incidence of lymph edema.

研究概览

简要总结

The incidence of Breast carcinoma related lymphedema [BCRL]is around 10 to 20 % and the incidence among Indian population is unknown. The lymphatic obstruction is been proposed as the main cause of the development of the lymph edema .But Venous hypertension is a coexisting feature of lymphoedema. Kim et al showed venous insufficiency in all 41 patients in their series with lymphoedema. All patients had increased venous pressure and volume with a decreased ejection fraction, all of which were proportional to the size of the swollen leg. Increased blood flow has been recorded in post mastectomy lymphoedema. This was thought to worsen the oedema present. Jacobsson [89] using radioactive isotope clearance showed a 42% increase in blood flow in 25 such arms. An increase in arterial flow that increases venous filling and causes venous hypertension was postulated. Svensson noted that 70% of post mastectomy lymphoedema patients had abnormal arm venous outflow. Solti suggested that the increased blood flow through the arm together with arteriovenous shunting caused by angiogenesis in lymphoedematous arms may lead to increased venous pressure.Based on these findings we proposed that by applying class 2 elastic compression stocking, the axillary venous outflow will increase and there by the venous hypertension will not be detrimental to the arm .The study design is double arm single blinded randomized controlled trial. Patients who undergo surgery for carcinoma breast will be randomized into two arms before the surgery.The arm volume and the arm circumference will be measured by a group of nursing staff who is blinded to the intervention. Post operatively within 24 hrs, according to the computer generated randomization nos, one group will receive the Class 2 elastic compression stocking from Siguvaris. The measurement will be taken on the 10th post operative and 90th day. The groups will be matched for the extent of the surgery and the disease and the analysis will be done

研究设计

分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

入选标准

  • All patients who needs surgery for carcinoma breast.

排除标准

  • Known filarial lymphodedma patients
  • Hypothyroid status
  • Fractures or other vascular anomaly /surgery in the arm.

结局指标

主要结局

Percentage of reduction in arm volume in the study group will be analyzed which will indirectly give the reduction in the incidence of lymph edema.

时间窗: on the 10 th post operative day and three months follw up

次要结局

  • Incidence of lymph edema(at the end of one year)

研究者

发起方
fluid research -institute

研究点 (1)

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