Status:

COMPLETED

Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction

Lead Sponsor:

Severance Hospital

Collaborating Sponsors:

European Institute of Oncology

Changhua Christian Hospital

Conditions:

Postoperative Complications

Recurrence

Eligibility:

FEMALE

Brief Summary

Robotic mastectomy with immediate reconstruction was introduced by Toesca et al. in 2015. Since then, several studies have reported the safety and feasibility of robotic nipple-sparing mastectomy with...

Detailed Description

This study is an international multi-center pooled analysis using prospective and retrospective studies to evaluate surgical and oncologic outcomes of robotic nipple-sparing mastectomy with immediate ...

Eligibility Criteria

Inclusion

  • Women who underwent nipple sparing mastectomy and immediate reconstruction
  • Women with early breast cancer
  • Women with germline BRCA 1/2 mutation or germline mutations in genetic susceptibility genes
  • Women with interstitial mastopathy
  • Women with risk-reducing mastectomy or contralateral mastectomy

Exclusion

  • Male patients
  • Women with stage IV disease at diagnosis
  • Women who underwent previous breast cancer surgery
  • Women who received prior radiotherapy for the ipsilateral breast

Key Trial Info

Start Date :

May 14 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 18 2022

Estimated Enrollment :

659 Patients enrolled

Trial Details

Trial ID

NCT04108117

Start Date

May 14 2020

End Date

May 18 2022

Last Update

September 11 2023

Active Locations (1)

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Yonsei University College of Medicine

Seoul, South Korea, 120-752