Robotic Versus Conventional or Endoscopic-assisted Nipple-sparing Mastectomy and Immediate Prosthesis Breast Reconstruction in the Management of Breast Cancer: A Prospectively Designed Multicenter Trial Comparing Clinical Outcomes, Medical Cost, and Patient-reported Outcomes (RCENSM-P)

Abstract

Objective: To compare the clinical and patient-reported outcomes of minimal access and conventional nipple-sparing mastectomy (C-NSM). The secondary outcomes investigated included medical costs and oncological safety.

Background: Minimal-access NSM has been increasingly applied in the treatment of patients with breast cancer. However, prospective multicenter trials comparing robotic-assisted NSM (R-NSM) versus C-NSM or endoscopic-assisted NSM (E-NSM) are lacking.

Methods: A prospectively designed 3-arm multicenter, nonrandomized trial (NCT04037852) was conducted from October 1, 2019 to December 31, 2021, to compare R-NSM with C-NSM or E-NSM.

Results: A total of 73 R-NSM, 74 C-NSM, and 84 E-NSM procedures were enrolled. The median wound length and operation time of C-NSM was (9 cm, 175 minutes), (4 cm, and 195 minutes) in R-NSM, and (4 cm and 222 minutes) in E-NSM. Complications were comparable among the groups. Better wound healing was observed in the minimal-access NSM group. The R-NSM procedure was 4000 and 2600 United States Dollars more expensive than C-NSM and E-NSM, respectively. Wound/scar and postoperative acute pain evaluation favored the use of minimal access NSM over C-NSM. Quality of life in terms of chronic breast/chest pain, mobility, and range of motion of the upper extremity showed no significant differences. The preliminary oncologic results showed no differences among the 3 groups.

Conclusions: R-NSM or E-NSM is a safe alternative if compared with C-NSM in terms of perioperative morbidities, especially with better wound healing. The advantage of minimal access groups was higher wound-related satisfaction. Higher costs remain one of the major limiting factors in the widespread adoption of R-NSM.

FIGURE 1

Flowchart of patients selected for R-NSM, C-NSM or E-NMS, and IPBR for surgical treatment of breast cancer. This is an open-label, nonrandomized, prospective, multicenter trial comparing 3 cohorts of patients (R-NSM vs C-NSM or E-NSM and IPBR).

FIGURE 2

Representative operative pictures showing C-NSM, E-NSM, and R-NSM with immediate prosthesis implant breast reconstruction. A, Photo showing surgeon performing C-NSM. B, Photo showing surgeon performing 3D (single port) E-NSM. C, Photo showing surgeon performing R-NSM. D, Representative view of the intraoperative finding of C-NSM. E, Representative view of the intraoperative finding of 3D E-NSM. F, Representative view of the intraoperative finding of R-NSM. G, Immediate postmastectomy view of C-NSM. H, Immediate postmastectomy view of 3D E-NSM. I, Immediate postmastectomy view of R-NSM. J, Photo showing an immediate postoperative view of patients receiving C-NSM and IPBR. K, Photo showing an immediate postoperative view of patients receiving 3D E-NSM and IPBR. L, Photo showing an immediate postoperative view of patients receiving R-NSM and IPBR. M, Photo showing postoperative 3 months right lateral view of the patient received C-NSM and IPBR. N, Photo showing postoperative 3 months left lateral view of the patient received 3D E-NSM and IPBR. O, Photo showing postoperative 3 months left lateral view of the patient received R-NSM and IPBR. 3D indicates 3-dimensional.

FIGURE 3

PROMs of esthetic results and QoL for patients receiving C-NSM, E-NSM, or R-NSM. A, Breast-Q “satisfaction with breast” domain. There was no statistically significant difference in satisfaction with breasts in patients who received C-NSM, E-NSM, or R-NSM procedures (P = 0.47). B, Breast-Q “psychosocial well-being” domain. There was no statistically significant difference in psychosocial well-being in patients who received C-NSM, E-NSM, or R-NSM procedures (P = 0.96). C, Breast-Q “sexual well-being” domain. There was no statistically significant difference in sexual well-being in patients who received C-NSM, E-NSM, or R-NSM procedures (P = 0.41). D, Breast-Q “physical well-being: breast/chest” domain. There was no statistically significant difference in physical well-being in patients who received C-NSM, E-NSM, or R-NSM procedures (P = 0.57). E, Wound-specific questionnaire for patients receiving various NSM and IPBR. The overall satisfaction was higher in patients receiving E-NSM or R-NSM group than in C-NSM (P = 0.02). F, VAS for pain score among patients receiving R-NSM versus C-NSM or E-NSM. E-NSM and R-NSM were associated with decreased VAS pain scores for the maximum pain experienced, day 1 and day 2. No differences were observed among the groups after day 3.