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
Dr Anita Dhar
All India Institute of Medical Sciences, New Delhi
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Evaluation of the Effectiveness of Manual Lymphatic Drainage in Young Women With Primary DysmenorrheaNCT07378475Camilo Jose Cela University20
尚未招募
不适用
Incidence of Lymphedema after Modified Radical MastectomyCTRI/2026/01/100357Government Medical College and Hospital Chandigarh50
招募中
2 期
Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC)NCT07263919Akeso90
招募中
3 期
Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon CancerNCT07412613Akeso386
招募中
不适用
Outcomes in ARMs: Comparison Between Surgical Techniques in Patients With Perineal or Vestibular Fistula - a Multicenter Italian StudyNCT07438691Meyer Children's Hospital IRCCS500
