Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA)

Overview

This study is the first prospective randomized study assessing the safety and patient-reported outcomes of immediate one-stage IBBR compared with those of two-stage IBBR with TiLoop® Bra.

Studies comparing two-stage implant-based breast reconstruction with immediate one-stage implant-based breast reconstruction have inconsistent results and investigators find that there is a lack of high quality evidence focusing on comparing one-stage and two-stage implant-based breast reconstruction with TiLoop®Bra. This study is the first prospective randomized study assessing the safety and patient-reported outcomes of immediate one-stage IBBR compared with those of two-stage IBBR with TiLoop® Bra in breast cancer patients. The hypothesis is that one step method is not inferior to two step method in implant based breast reconstruction following skin-sparing and/or Nipple-sparing mastectomy using TiLoop® Bra. The current study is a randomized multicenter, open labeled, prospective, controlled study. Participants were enrolled at six hospitals in different places of China. All participants will undergo Skin Sparing Mastectomy(SSM)/Nipple Sparing Mastectomy(NSM) with one-stage or two stage IBBR with TiLoop® Bra. Based on earlier experience, investigators calculated that the surgical complication rate was approximately 30 percent in the one-stage group and 25 percent in the two-stage group. Consider a dropout rate of 5%, a total of 450 patients, with 225 in each group, are needed.

Conditions

Interventions

Eligibility

Locations (11)

Outcomes