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临床试验/CTRI/2026/01/100357
CTRI/2026/01/100357尚未招募不适用

Incidence of Lymphedema after Modified Radical Mastectomy

Government Medical College and Hospital Chandigarh1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年1月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Incidence of lymphedema in post Modified Radical Mastectomy patients

研究概览

简要总结

Lymphedema is fluid buildup in the interstitial space due to impaired lymphatic drainage, often caused by surgery, cancer, radiation, or infection. Breast cancer-related lymphedema (BCRL) commonly affects the arm after treatments like axillary lymph node dissection (ALND) and/or radiation. A meta-analysis reported a 21.4% incidence of BCRL, though estimates range from 5% to 89% due to varying diagnostic criteria. Symptoms include arm swelling, heaviness, tightness, and discomfort. BCRL severity is classified based on excess arm volume: mild (<20%), moderate (20–40%), and severe (>40%). Despite advances in treatment, BCRL remains a concern, especially in patients undergoing both ALND and radiation. It can cause pain, reduced mobility, recurrent infections, and psychological issues. Diagnosis methods include limb circumference measurements, water displacement, MRI, bioimpedance spectroscopy, and perometry. A common approach is measuring arm circumference every 4 cm and calculating volume using the truncated cone formula. Early detection is key to managing BCRL effectively.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
Female

入选标准

  • All adult female patients with breast cancer undergoing Modified Radical Mastectomy.
  • All patients consenting for the study.

排除标准

  • Patients presenting with recurrent breast cancer.
  • Patients with contralateral breast cancer who have previously undergone Modified Radical Mastectomy/Radiation therapy.
  • Patients having undergone prior surgery for any upper limb condition.

结局指标

主要结局

Incidence of lymphedema in post Modified Radical Mastectomy patients

时间窗: Arm volume to be measured once at the time of admission (Baseline), 10 weeks and 24 weeks

次要结局

未报告次要终点

研究者

发起方
Government Medical College and Hospital Chandigarh
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Tejinder Kaur

Govt Medical College and Hospital, Sector-32, Chandigarh

研究点 (1)

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