To Study The Predictors of Lymphedema in Ipsilateral Arm in Patients treated with Modified Radical Mastectomy for Breast Cancer-A Prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To study the Patient factors & Tumour factors as Predictors of Arm Lymphedema in breast cancer patients undergoing Modified Radical Mastectomy
研究概览
简要总结
•Samplesize: All Breast cancer patients presenting to OPD during the study duration.
•Samplesize calculation was done By Fleiss formula with continuity correction andminimum sample size was calculated to be 150
•StudyDuration : 18 months
•StudyDesign : Prospective Observational study
•DataCollection Methods : A structured proforma will be made and demographic andclinical data will be collected at pre defined intervals: 0, 1 and 6 months
•Definitionof lymphedema :Post-surgical Arm lymphedema represents the increase of the armvolume over 10% which occurs in the first 3 months aftersurgical treatment.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.All Female Patients >18 years of age with Biopsy proven Infiltrating Ductal Carcinoma (Adenocarcinoma) Breast cancer who underwent Modified Radical Mastectomy 2.Giving Informed consent for being included in the study.
排除标准
- •Preexisting Lymphedema of the Ipsilateral arm.
- •Axillary Vein thrombosis Metastatic Breast cancer Bilateral breast cancer Recurrent breast cancer.
结局指标
主要结局
To study the Patient factors & Tumour factors as Predictors of Arm Lymphedema in breast cancer patients undergoing Modified Radical Mastectomy
时间窗: To study the Patient factors & Tumour factors as Predictors of Arm Lymphedema in breast cancer patients undergoing Modified Radical Mastectomy | Lymphedema/arm size will be recorded at baseline 1 month, 3 months and 6 months
次要结局
- To find the Prevalence of Arm Lymphedema in patients who have undergone Modified Radical Mastectomy.
- Compare prevalence of Arm Lymphedema in patients who have undergone Modified Radical Mastectomy among different stages of Breast cancer.