Surgical Cosmesis And patient reported outcome measures in patients who have undergone tRansposition flap reconstruction after BCS (SCAR)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Patient reported outcome measure obtained by the BREAST-Q BCS module.
研究概览
简要总结
1. Aim
To analyse the Surgical Cosmesis And patient reported outcome measures in patients who have undergone tRansposition flap reconstruction after BCS .
**2.**Objectives
Primary Objective:
1. Patient reported outcome measure obtained by the BREAST-Q BCS module
Secondary Objectives:
1. Clinical outcome parameters such as margin positive rate, local recurrence and disease-free survival.
2. Subjective cosmetic assessment by Modified Harvard Scale5
3. Objective cosmetic assessment by BCCT.Core software
4. Surgical morbidity rate
Materials And Methods
Patients operated from Jun 2014 till Jun 2023 with transposition flap surgery with BCS will be screened during their routine follow-up visits, starting at first follow up- which is 6 months post radiation. They will be then administered the Informed Consent Form and the study will be explained in detail to them. After willing to voluntarily participate in the study and signing the ICF, the patients will be administered the BREAST-Q BCS module (Baseline Visit).
Patients’ clinical photographs will be taken to assess the cosmesis objectively using the BCCT.core software.
Subjective assessment will be done independently by breast oncoplastic or plastic surgeon and clinical photographs will be taken at the same time.
As per routine, mammogram will be done during the follow up.
The BREAST-Q BCS questionnaire has been recently translated by us in Hindi and Marathi and validation from the MAPI Trust is in the process. [The translated and the original English versions are attached here as annexure (2)].
This will be a single timepoint cross sectional analysis of outcomes. Clinico-pathological data is prospectively maintained and further information will be collected from electronic medical records (EMR) to analyse oncological outcomes like margin positivity, cancer recurrence, locally or distally. Any history of surgical morbidity- clinical or radiological- will be recorded- For e.g. Fat necrosis, wound infection, flap necrosis, etc.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.All patients who have undergone a breast conservative surgery (from Jun 2014 to June 2023) with a Transposition Flap 2.All patients willing for the study.
排除标准
- •1.All patients undergoing procedures other than Transposition Flap.
- •2.All metastatic patients.
- •3.Patients not willing to give consent.
- •4.Pregnant women.
结局指标
主要结局
Patient reported outcome measure obtained by the BREAST-Q BCS module.
时间窗: the patients will be administered the BREAST-Q BCS module at Baseline visit
次要结局
- 1.Clinical outcome parameters such as margin positive rate, local recurrence and disease-free survival.(2.Subjective cosmetic assessment by Modified Harvard Scale5)
研究者
Dr Shalaka P Joshi
Tata Memorial Hosiptal