NCT06823414招募中不适用
Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy and Inmediate Reconstruction With Prepectoral Implant. Prospective Study for the Evaluation of the Feasibility and Safety of the Technique, Quality of Life and Cosmetic Results
Alejandra García-Novoa1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2025年2月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Implant Loss
研究概览
简要总结
Non-inferiority study of video-assisted (endoscopic or robotic) skin- and nipple-sparing mastectomy compared to open mastectomy. The feasibility of the technique, oncological safety and cosmetic results will be studied.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who require a mastectomy and who do not require skin reduction or resection are included. Women with both breast cancer and those at high risk for breast cancer are included.
排除标准
- •Sarcomas of the breast.
- •Benign breast tumors.
- •Prepectoral reconstruction with expansion.
- •Impossibility to preserve the skin.
- •Need for reduction pattern
- •Inability to perform an MRI during follow-up (obesity, claustrophobia, etc.).
- •Inability to complete the BREAST-Q™ questionnaire due to the patient's cognitive alterations.
- •Refusal of the patient to participate in the study.
结局指标
主要结局
Implant Loss
时间窗: First year after surgery
Safety of the reconstruction technique, calculated by the number of implants lost
次要结局
- local relapse(first 5 years)
- Suvival(5 years)
- Glandular residual tissue(first year)
研究者
Alejandra García-Novoa
Principal Investigator
University Hospital A Coruña
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy for Breast CancerBreast Cancer FemaleNCT04049305Changhua Christian Hospital900
已完成
不适用
Volume Navigation System Guided Breast Biopsy for Incidental Enhancing Lesions Detected by MRIIncidental Enhancing Lesions (IEL) Detected by MRIJPRN-UMIN000017321Keio University Hospital50
招募中
Unknown
Transaxillary posterior breast conserving surgery for operable breast cancer with volume replacement using diced acellular dermal matrixNeoplasmsKCT0008401The Catholic University of Korea, St. Vincent's Hospital3
已完成
不适用
Simplifying the sentinel node procedure in breast cancer using a portable gamma camera in order to replace conventional preoperative lymphatic mapping.NL-OMON45614Antoni van Leeuwenhoek Ziekenhuis236
Unknown
不适用
Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy in the Management of Breast Cancer-Prospective StudyBreast Cancer FemaleNCT04037852Changhua Christian Hospital180