A National Multicenter, Prospective, Cohort Study Comparing Delayed Endoscopic Direct-to-Implant Breast Reconstruction Via Axillary Approach With the Two-Stage Expander-to-Implant Breast Reconstruction Following Simple Mastectomy

Breast cancer is one of the most prevalent malignant tumors among women, with comprehensive treatment primarily centered around surgery being the mainstay approach. Mastectomy accounts for 88.8% of primary breast cancer surgeries, yet the rate of immediate breast reconstruction is only about 10.7%, resulting in the majority of patients losing their breasts at the time of initial surgery and suffering from long-term suboptimal psychosocial health, with divorce rates reaching as high as 40%. With the improvement in breast cancer treatment outcomes, an increasing number of women hope to improve postoperative breast morphology and alleviate psychological trauma through breast reconstruction. Traditional reconstruction methods include autologous tissue reconstruction and prosthetic reconstruction. The former involves significant trauma and a high incidence of complications, while the latter often requires a two-stage approach due to insufficient skin tissue, involving initial placement of a tissue expander followed by replacement with a prosthetic implant, which increases the number of surgeries and the risk of complications.

To address this issue, our team has developed a novel delayed endoscopic direct-to-implant breast reconstruction technique via an axillary incision approach with insufflation, which requires only a single surgery, significantly reducing surgical time, trauma, and costs, as well as the incidence of complications. Postoperatively, there are no fresh incisions on the breast, resulting in a more natural appearance and softer feel. This study aims to compare this technique with the traditional two-stage approach, exploring postoperative complications, aesthetic outcomes, quality of life, cost-effectiveness, and surgical-related indicators. To comprehensively evaluate its clinical benefits, large-scale multicenter studies are required to provide evidence-based medical evidence and optimize surgical strategies.

Therefore, this national multicenter, prospective, cohort study will compare surgical safety (e.g., surgical complication rates), surgery-related indicators (e.g., operation time, number of operations, surgery-related costs, contralateral breast adjustment operation rates), aesthetic outcomes (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores, Ueda scores and QLQ-BR45 scores), and divorce rate between patients undergoing delayed endoscopic direct-to-implant breast reconstruction via an axillary approach and those undergoing the two-stage expander-to-implant breast reconstruction following simple mastectomy.