Prospective Non-randomized Evaluation of Oncoplastic Surgery (iTOP)
2015年9月22日 更新者：Florian Fitzal、Medical University of Vienna
Prospective Trial Evaluating Cosmetic And Oncologic Outcome Of Immediate Techniques For Oncoplastic Surgery In Breast Cancer
Breast conserving therapy (BCT) is the standard treatment for intraductal or invasive breast cancer patients.
However cosmetic results, e.g.
symmetry and nipple displacement, are sometimes poor reducing the quality of life.
The use of immediate techniques for oncoplastic surgery (iTOP) seems to improve subjective cosmetic outcome.
Oncologic safety of iTOP has been demonstrated by several authors using restrospective analyses.
However, no prospective observational trial has been done to objectively evaluate cosmetic and oncologic outcome comparing BCT with iTOP.
The aim of this study is to investigate this issue within a prospective non randomized observational trial at the Medical University Vienna.
研究概览
地位
未知
条件
研究类型
观察性的
注册 (预期的)
150
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Vienna、奥地利、1090
- Medical University Vienna
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
取样方法
非概率样本
研究人群
Patients with a BIRADS IV, V or VI breast lesion are preoperatively asked to take part in this study if more than 10% of breast tissue will be excised or mastectomy and immediate reconstruction is planned.
Patients with planned mastectomy without immediate reconstruction are not included.
Patients scheduled for breast conservation can decide whether they undergo regular breast conservation (BCT) or BCT using immediate techniques of oncoplastic surgery (iTOP).
A contralateral correction may be performed in both groups at any time of the trial.
The use of a contralateral correction of patients without an immediate oncoplastic procedure does not initiate a change into the other group (intention to treat analyses).
描述
Inclusion Criteria:
- Patients scheduled for unilateral breast conserving surgery due to cancer or a suspicious lesion, in whom >10%* of breast volume (measured by mammograms using a defined formular 37) has to be removed or breast cancer patients scheduled for mastectomy and immediate reconstruction (immediate or delayed contralateral correction is allowed)
- BIRADS IV, V or VI are eligible
- > 18 years of age
- Psychological and physical capable of understanding and performing the trial
- Signed written informed consent * If oncologic safety necessitates to resect more than half of one breast quadrant
Exclusion Criteria:
- Inflammatory breast cancer
- Progression after neoadjuvant therapy
- Pregnant women
- Patients unable to perform surgery under general anaesthesia
- Bilateral breast lesions
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
iTOP
Patients undergoing immediate techniques for oncoplastic surgery (level I only parenchmyl rotation and breast undermining as well as level II using complex reduction plastics for nipple-areola-complex movings) and patients with mastectomy and immediate reconstruction
|
breast conserving surgery AND immediate defect filling using local flaps (level I) or reduction plastics (level II) as well as mastectomy and immediate reconstruction using free flaps
Breast conserving therapy without defect correction
|
|
BCT
patients undergoing conservative breast surgery
|
breast conserving surgery AND immediate defect filling using local flaps (level I) or reduction plastics (level II) as well as mastectomy and immediate reconstruction using free flaps
Breast conserving therapy without defect correction
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
breast image scale
大体时间：2 years
|
self esteem measured by the breast image scale will be assessed before and every 6 months after surgery as primary endpoint.
|
2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
quality of life
大体时间：2 years
|
BREAST Q, non-validated questionnaires
|
2 years
|
|
Morbidity
大体时间：6 months
|
Necrosis, infection, reoperations and bleedings as well as heamtoma and seroma formation will be clinically assessed after surgery
|
6 months
|
|
breast symmetry index
大体时间：2 years
|
Using the breast analyzing tool software we will analyze breast symmetry before and every 6 months after surgery
|
2 years
|
|
oncologic parameters
大体时间：2-5 years
|
local, distent and overal survival 2 as well as 5 years after surgery will be assessed
|
2-5 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年7月1日
初级完成 (实际的)
2015年7月1日
研究完成 (预期的)
2016年8月1日
研究注册日期
首次提交
2011年7月18日
首先提交符合 QC 标准的
2011年7月18日
首次发布 (估计)
2011年7月19日
研究记录更新
最后更新发布 (估计)
2015年9月23日
上次提交的符合 QC 标准的更新
2015年9月22日
最后验证
2015年9月1日
更多信息
与本研究相关的术语
其他研究编号
- iTOP
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.