跳至主要内容
临床试验/CTRI/2024/10/075086
CTRI/2024/10/075086尚未招募4 期

A Randomised trial to study the outcome of addition of Lymphatico-venous Anastomosis to standard of care for prevention of upper extremity Lymphedema in patients undergoing Axillary Lymph Node Dissection for Carcinoma Breast as compared to standard of care only.

Department of Surgical Disciplines1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年10月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
The primary outcome will be the presence of Lymphedema of upper limb on the operated side at 6 months.

研究概览

简要总结

MRM
involves the removal of axillary lymph nodes, disrupting the normal lymphatic
drainage system of the arm and breast. There are common channel lymphatics
draining axilla and upper arm. This leads to Lymphedema.

Lymphedema can significantly impact a patient’s quality of life, causing discomfort, functional impairment, and psychological distress.

There are existing strategies for lymphedema prevention, such as lymphatic drainage techniques and compression therapy.

Lymphatico-venous Anastomosis (LVA) involves connecting lymphatic vessels directly to nearby veins, which may help to establish alternative drainage pathways for lymph fluid, thereby reducing the risk of lymphedema.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
Female

入选标准

  • All female patients planned for ALND whether post NACT or in upfront setting.

排除标准

  • 未提供

结局指标

主要结局

The primary outcome will be the presence of Lymphedema of upper limb on the operated side at 6 months.

时间窗: 2 weeks, 4 weeks, 8 weeks, 16 weeks, 20 weeks and 6 months

次要结局

  • 1. Assessment of quality of life by EORTC questionnaire C30/+BR23.(2. Surgical site infection)

研究者

发起方
Department of Surgical Disciplines
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Anita Dhar

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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