Cosmetic Outcomes and Quality of Life in patients undergoing Breast Conservation Surgeryfor Carcinoma Breast- An Ambispective Observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To assess the cosmetic outcome in breast cancer patients undergoing/undergone Breast Conservation (BCS) surgery using objective assessment tool - BCCT.core software.
研究概览
简要总结
• This is an ambispective observational study on cosmetic outcomes and quality of life in patients undergoing breast conservational surgery for Carcinoma Breast under the Department of Surgical Oncology**.** Total 51 patients of breast cancer underwent Breast Conservation Surgery between January-December 2023. Thus we aim to include minimum 120 patients (50 patients prospectively and 70 patients retrospectively) during the study period. Patients are included in study based on fixed inclusion criteria. Primary objectives of the study is to assess the cosmetic outcome and quality of life of the patients undergoing BCS and secondary outcomes are complications associated with the procedure and other associated factors. Data will be collected both prospectively and retrospectively from inpatients and medical records respectively. For cosmetic outcomes, BCCT core and to assess quality of life, BREAST Q questionnaire will be used.
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
- All
入选标准
- •All biopsy proven breast cancer patients with stage (cT1-3 N1-2 M0) who will undergo/ underwent breast conservation surgery upfront or post neoadjuvant chemotherapy.
排除标准
- •Previous history of mastectomy on contralateral side.
- •Present history of bilateral carcinoma breast warranting mastectomy on one side.
- •Not giving informed consent.
- •Incomplete medical records (for retrospective patients) 5)Patients who are unable to read or understand English/Hindi for completing the quality of life (QOL) questionnaire, as well as those with psychiatric illnesses that may interfere with subjective assessment of cosmesis and QOL.
结局指标
主要结局
To assess the cosmetic outcome in breast cancer patients undergoing/undergone Breast Conservation (BCS) surgery using objective assessment tool - BCCT.core software.
时间窗: To assess the cosmetic outcome in breast cancer patients undergoing/undergone Breast Conservation (BCS) surgery using objective assessment tool - BCCT.core softwareat 4 weeks and 6 months .
次要结局
- 1. To analyze various clinical and surgical factors to determine the key factors affecting cosmetic outcomes in patients undergoing breast conservation surgery.(2. To compare cosmetic outcomes among patients undergoing breast conservation (BCS) with conventional closure, BCS with volume displacement oncoplasty and BCS with volume replacement oncoplasty)
研究者
Dr Chandralal PG
Department of Surgical Oncology,AIIMS Jodhpur