About this trial
Robotic surgical systems provide notable advantages including enhanced dexterity, a magnified three-dimensional high-definition view, and high-resolution imaging, thereby improving operative stability and precision. These features make robotic systems particularly suitable for procedures performed within confined operative spaces. As the breast is a solid organ without a natural cavity, robotic systems demonstrate strong adaptability for breast surgery. Robot-assisted breast-conserving surgery (RABCS) is one of the currently utilized robotic techniques in clinical breast cancer surgery. However, as robotic breast surgery remains in its early stage of development, evidence regarding the clinical outcomes of RABCS remains limited in the literature. Therefore, this study compares the surgical outcomes of endoscopic breast-conserving surgery and robot-assisted breast-conserving surgery in breast cancer patients, aiming to assess and elucidate the clinical value of RABCS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged 18 to 80 years
Pathologically confirmed breast cancer prior to surgery
Sufficient glandular volume with a tumor-to-breast volume ratio ≤20%
A unifocal lesion confined to the glandular tissue
Disqualifiers
The presence of diffuse suspicious lesions or microcalcifications for which wide local resection was unlikely to achieve adequate negative margins or satisfactory aesthetic outcomes
Bilateral breast cancer or inflammatory breast cancer
After neoadjuvant therapy, requirement for additional concurrent surgical procedures
Inability to tolerate general anesthesia or undergo surgery
Trial design
Parallel
Treatments tested in this trial
Robotic breast-conserving surgery
Procedure/SurgeryTo perform breast-conserving surgery using a robotic system, thereby validating the safety and feasibility of robotic breast-conserving surgery.
Endoscopic breast-conserving surgery
Procedure/SurgeryTo perform breast-conserving surgery using a endoscopic system.
Treatment groups
Trial outcomes
Primary outcomes
Postoperative complication rate
Secondary outcomes
Operation time
Aesthetic outcomes
We utilized the novel assessment tool developed by Lai et al. tailored to minimally invasive breast surgery, with specific attention to scar length, appearance, and position. References: Lai HW, Mok CW, Chang YT, Chen DR, Kuo SJ, Chen ST. Endoscopic assisted breast conserving surgery for breast cancer: Clinical outcome, learning curve, and patient reported aesthetic results from preliminary 100 procedures. Eur J Surg Oncol. 2020;46(8):1446-1455. doi:10.1016/j.ejso.2020.02.020
Blood loss
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