Breast Cancer, Breast Surgery
Conditions
Brief summary
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.
Interventions
PROCEDURERobotic breast-conserving surgery
To perform breast-conserving surgery using a robotic system, thereby validating the safety and feasibility of robotic breast-conserving surgery.
PROCEDUREEndoscopic breast-conserving surgery
To perform breast-conserving surgery using a endoscopic system.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Clear desire for breast conservation and willingness to undergo R-BCS or E-BCS * No evidence of distant metastasis, no involvement of the skin or chest wall * Eligibility for standard postoperative radiotherapy
Exclusion criteria
* 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 * Contraindications to radiotherapy or a history of prior chest wall irradiation, pregnancy- or lactation-associated breast cancer * Refuse to undergo R-BCS or E-BCS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative complication rate | 1 month postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operation time | Intraoperative | — |
| Aesthetic outcomes | 3 month postoperatively | 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 | Perioperative | — |
Countries
China
Contacts
Primary ContactHaiyan Li
Outcome results
None listed