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Surgical and Patient Reported Outcomes in Robotic Mastectomy

NCT06335550 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-03-28

No results posted yet for this study

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

Interventions

PROCEDURE

Robotic mastectomy

Robotic mastectomy with or without reconstruction

Sponsors & Collaborators

  • Changi General Hospital

    lead OTHER

Principal Investigators

  • Chi Wei Mok · Changi General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-24
Primary Completion
2023-12-31
Completion
2024-03-01

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06335550 on ClinicalTrials.gov