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

NCT04108117 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 659

Last updated 2023-09-11

No results posted yet for this study

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 immediate reconstruction. However, most studies were conducted by single centers and had small samples. Furthermore, there is a lack of studies comparing surgical and oncologic outcomes between robotic nipple-sparing mastectomy and conventional nipple-sparing mastectomy. For this reason, this study evaluates surgical and oncologic outcomes of robotic nipple-sparing mastectomy with immediate reconstruction using international multi-center data.

Conditions

  • Postoperative Complications
  • Recurrence
  • Breast Neoplasms
  • Breast Cancer
  • BRCA1 Mutation
  • BRCA2 Mutation
  • Surgery
  • Surgery--Complications

Interventions

PROCEDURE

Robotic nipple sparing mastectomy

Robotic nipple sparing mastectomy means nipple sparing mastectomy performed using robotic surgical systems.

Sponsors & Collaborators

  • European Institute of Oncology

    collaborator OTHER

  • Changhua Christian Hospital

    collaborator OTHER

  • Samsung Medical Center

    collaborator OTHER

  • Severance Hospital

    lead OTHER

Principal Investigators

  • Hyung Seok Park, MD, PhD · Severance Hospital

  • Antonio Toesca, MD · European Institute of Oncology

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-14
Primary Completion
2022-05-04
Completion
2022-05-18

Countries

  • South Korea

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 NCT04108117 on ClinicalTrials.gov