跳至主要内容
临床试验/NCT06738654
NCT06738654招募中不适用

Application of Single-Port Robot-Assisted Breast-Conserving Surgery Via Axillary Approach for Breast Cancer.

Xu Yan2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年12月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
64
试验地点
2
主要终点
The successful rate of breast-conserving surgery

研究概览

简要总结

Evaluate the safety,feasibility and quality of life(QoL)of single-port robotic surgery in breast-conserving surgery, compare and analyze the advantages and disadvantages of single-port robotic surgery and open surgery in terms of complications, postoperative complications, perioperative recovery effects, and safety in breast cancer breast-conserving surgery, in order to select a more effective and safe surgical method. Subjects who meet the inclusion criteria will enter the research process, with surgery including SPr-breast-conserving surgery or open-breast-conserving surgery, and the choice of the two surgical methods is based on the patient's financial situation and the availability of equipment;

详细描述

Evaluate the safety and feasibility of single-port robotic surgery in breast-conserving surgery, compare and analyze the advantages and disadvantages of single-port robotic surgery and open surgery in terms of complications, postoperative complications, perioperative recovery effects, and safety in breast cancer breast-conserving surgery, in order to select a more effective and safe surgical method. Subjects who meet the inclusion criteria will enter the research process, with surgery including SPr-breast-conserving surgery or open-breast-conserving surgery, and the choice of the two surgical methods is based on the patient's financial situation and the availability of equipment; - Preoperative hospitalization period: Collect patient disease information (including mammography, breast ultrasound, breast enhanced MRI, etc.) - On the day of surgery: Record operating time, intraoperative blood loss, intraoperative complications, intraoperative adverse events, etc.; - Postoperative hospitalization period: Record postoperative complications (postoperative bleeding, necrosis of the flap or nipple-areola complex, subcutaneous emphysema, infection, capsule spasm, postoperative shoulder pain and discomfort, etc.), postoperative pain scores, postoperative pathological biopsy; - Postoperative hospital stay: Calculated from the day of surgery to the day of discharge; - 28 days postoperatively: Understand the complication rate and mortality rate within 28 days postoperatively; - 90 days postoperatively: Understand the complication rate and mortality rate within 90 days postoperatively; - 3-year disease-free survival period (calculated from the time of surgery to the last follow-up or recurrence and metastasis date, recurrence is defined as recurrence in the surgical area and distant metastasis); - 3-year overall survival rate (calculated from the time of surgery to the last follow-up or death).

In addition, postoperative quality of life and psychosocial satisfaction were assessed in all patients. Questionnaire surveys for quality of life were conducted at 1 week, 1 month, 3 months, 6 months, 12 months, 24 months and 36 months after surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • The patient himself has very high requirements for beauty, and requires no scar on the chest;
  • No chest surgery and radiotherapy.
  • No contraindications to surgery and anesthesia.
  • Clinical I, stage of early breast cancer and the breast has an appropriate volume, can maintain a good breast shape after surgery.
  • Patients in the clinical period who meet the standard of breast conservation surgery after preoperative treatment.
  • Age: ≥18 years old.

排除标准

  • Inflammatory breast cancer.
  • The tumor is extensive and it's difficult to achieve negative margins or an ideal breast - conserving appearance.
  • Diffusely distributed malignant - characteristic calcifications.
  • The margin is positive after local extensive tumor resection, and a negative margin in pathological examination still can't be ensured after re - resection.
  • The patient refuses.

研究组 & 干预措施

Control Group

Active Comparator

Breast-conserving surgery for breast cancer using traditional open surgery.

干预措施: traditional open surgry (Procedure)

Experimental Group

Experimental

Breast-conserving surgery for breast cancer using single-port robotic surgery.

干预措施: robot-surgery (Procedure)

结局指标

主要结局

The successful rate of breast-conserving surgery

时间窗: From enrollment to the end of treatment at 2 weeks

Whether intraoperative frozen section biopsy of the surgical margins detects cancer cells; if it is negative after two or fewer attempts, then the breast-conserving surgery is considered successful.

次要结局

未报告次要终点

研究者

发起方
Xu Yan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xu Yan

Yan Xu,MD., PhD. Department of Breast and Thyroid Surgery Daping Hospital, Army Medical University

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

研究点 (2)

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