NCT06335550

Surgical and Patient Reported Outcomes in Robotic Mastectomy

Pilot Robotic Mastectomy in Singapore (PRoMiSing I) Study: First Safety and Feasibility Prospective Cohort Study in South East Asia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Changi General Hospital · Academic / Other
• Sex: Female
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Conventional nipple and/or skin-sparing mastectomy (NSM/SSM) with or without immediate reconstruction is becoming one of the mainstream surgical treatment for breast cancer and risk reducing mastectomy in recent years. While this technique provides satisfactory oncologic and aesthetic outcomes, its disadvantages include skin flap and/or nipple-areolar complex (NAC) necrosis, NAC malposition/distortion as well as visible scar(s) on the breast. In terms of technical aspects, NSM/SSM has its inherent challenges in view of limited incisions and thereby difficulties in dissection. Since 2015, a number of institutions worldwide had adopted a new technique of NSM/SSM using robotic surgical system. Institutional experiences worldwide demonstrated feasibility and safety of this technique coupled with improved patients' satisfactions. To date, there is no center in Singapore or the region offering Robotic NSM/SSM (R-NSM/R-SSM). The authors believe that robotic mastectomy is a feasible and safe technique that can be utilized in our institution and it provides superior aesthetic outcomes with less morbidity and higher patient satisfaction if compared to conventional NSM/SSM. The aim of this study is to conduct a single-arm prospective pilot study to investigate the safety and feasibility as well as learning curve of R-NSM/R-SSM.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Robotic mastectomy	Robotic mastectomy with or without reconstruction

Timeline

• Start date: 2022-11-24
• Primary completion: 2023-12-31
• Completion: 2024-03-01
• First posted: 2024-03-28
• Last updated: 2024-03-28

Locations

1 site across 1 country: Singapore