Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction
NCT ID: NCT04108117
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
659 participants
OBSERVATIONAL
2020-05-14
2022-05-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Surgical and Patient Reported Outcomes of Robotic Nipple-Sparing Mastectomy
NCT04151368
Robotic Nipple Sparing Mastectomy with Immediate Reconstruction
NCT06860217
Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery
NCT04585074
Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction
NCT05490433
Surgical and Patient Reported Outcomes in Robotic Mastectomy
NCT06335550
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Raw data for robotic or conventional nipple-sparing mastectomy from Severance Hospital, Samsung Medical Center, the European Institute of Oncology, Changhua Christian Hospital, and Gustave Roussy is collected. Among them, Severance Hospital takes the lead at performing analysis from the data. Storage and disposal of patients' records are managed by each researcher. In the analysis process, although the collaborators can request records from Severance Hospital if necessary, they are only supposed to be provided computerized data which were originally clinical data from patients who already ended treatments. In this case, individual identifying data and medical records are not shown.
Clinicopathologic variables including operation times, hospital stay, medical history, smoking history, family history, BMI, menopausal status, specimen weight, TNM stage, grade, histological type, estrogen receptor, progesterone receptor, HER2, Ki 67, and perivascular involvement are analyzed.
Postoperative complications within 30 days are collected and classified by the Clavien-Dindo grade. Locoregional recurrence-free survival and local and systemic recurrences are examined. Patients whose data have been retrospective for at least one month are to be examined.
Patient's and surgeon's satisfaction using Breast Q is evaluated. Categorical variables are examined using the chi-square test or Fisher's exact test if indicated.
Continuous variables are examined using the independent t-test or ANOVA if indicated.
The estimated sample size from the four institutions is about 300 cases for robotic nipple-sparing mastectomy and matched cases for conventional nipple-sparing mastectomy.
Propensity matching analysis is applied to reduce confounding factors.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Robotic nipple sparing mastectomy group/RNSM
Cases or Patients who underwent robotic nipple-sparing mastectomy and immediate reconstruction are enrolled in this arm. Robotic nipple-sparing mastectomy should be performed using robotic surgical systems. Robotic surgical systems include da Vinci S,Si, X, Xi, and SP systems. Axillary or lateral incisions are used for this procedure. Immediate reconstruction includes tissue expander insertion, direct-to-implant, latissimus dorsi flap, transverse abdominis rectus muscle flap, or deep inferior epigastric perforators flap. Cases with robotic mastectomy without immediate reconstruction are excluded.
The estimated sample size for this arm is 300 cases.
Robotic nipple sparing mastectomy
Robotic nipple sparing mastectomy means nipple sparing mastectomy performed using robotic surgical systems.
Conventional nipple sparing mastectomy group/CNSM
Cases or Patients who underwent conventional nipple-sparing mastectomy and immediate reconstruction are enrolled in this arm. Conventional nipple-sparing mastectomy should not be performed using robotic or endoscopic surgical systems. Axillary or lateral incisions that are similar to incisions in robotic nipple-sparing mastectomy are not allowed. Other than axillary or lateral incisions can be performed for this procedure. Immediate reconstruction includes tissue expander insertion, direct-to-implant, latissimus dorsi flap, transverse abdominis rectus muscle flap, or deep inferior epigastric perforators flap. Cases with nipple-sparing mastectomy without immediate reconstruction are excluded.
The estimated sample size for this arm is 300 cases.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Robotic nipple sparing mastectomy
Robotic nipple sparing mastectomy means nipple sparing mastectomy performed using robotic surgical systems.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* Women with stage IV disease at diagnosis
* Women who underwent previous breast cancer surgery
* Women who received prior radiotherapy for the ipsilateral breast
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Institute of Oncology
OTHER
Changhua Christian Hospital
OTHER
Samsung Medical Center
OTHER
Severance Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hyung Seok Park, MD, PhD
Clinical Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hyung Seok Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Antonio Toesca, MD
Role: PRINCIPAL_INVESTIGATOR
European Institute of Oncology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yonsei University College of Medicine
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Toesca A, Peradze N, Manconi A, Galimberti V, Intra M, Colleoni M, Bonanni B, Curigliano G, Rietjens M, Viale G, Sacchini V, Veronesi P. Robotic nipple-sparing mastectomy for the treatment of breast cancer: Feasibility and safety study. Breast. 2017 Feb;31:51-56. doi: 10.1016/j.breast.2016.10.009. Epub 2016 Nov 2.
Park HS, Kim JH, Lee DW, Song SY, Park S, Kim SI, Ryu DH, Cho YU. Gasless Robot-Assisted Nipple-Sparing Mastectomy: A Case Report. J Breast Cancer. 2018 Sep;21(3):334-338. doi: 10.4048/jbc.2018.21.e45. Epub 2018 Sep 20.
Galimberti V, Morigi C, Bagnardi V, Corso G, Vicini E, Fontana SKR, Naninato P, Ratini S, Magnoni F, Toesca A, Kouloura A, Rietjens M, De Lorenzi F, Vingiani A, Veronesi P. Oncological Outcomes of Nipple-Sparing Mastectomy: A Single-Center Experience of 1989 Patients. Ann Surg Oncol. 2018 Dec;25(13):3849-3857. doi: 10.1245/s10434-018-6759-0. Epub 2018 Sep 17.
Toesca A, Peradze N, Galimberti V, Manconi A, Intra M, Gentilini O, Sances D, Negri D, Veronesi G, Rietjens M, Zurrida S, Luini A, Veronesi U, Veronesi P. Robotic Nipple-sparing Mastectomy and Immediate Breast Reconstruction With Implant: First Report of Surgical Technique. Ann Surg. 2017 Aug;266(2):e28-e30. doi: 10.1097/SLA.0000000000001397. No abstract available.
Toesca A, Peradze N, Manconi A, Nevola Teixeira LF. Reply to the letter to the editor "Robotic-assisted Nipple Sparing Mastectomy: A feasibility study on cadaveric models" by Sarfati B. et al. J Plast Reconstr Aesthet Surg. 2017 Apr;70(4):558-560. doi: 10.1016/j.bjps.2016.12.022. Epub 2017 Jan 23. No abstract available.
Lai HW, Wang CC, Lai YC, Chen CJ, Lin SL, Chen ST, Lin YJ, Chen DR, Kuo SJ. The learning curve of robotic nipple sparing mastectomy for breast cancer: An analysis of consecutive 39 procedures with cumulative sum plot. Eur J Surg Oncol. 2019 Feb;45(2):125-133. doi: 10.1016/j.ejso.2018.09.021. Epub 2018 Oct 17.
Lai HW, Lin SL, Chen ST, Chen SL, Lin YL, Chen DR, Kuo SJ. Robotic Nipple-sparing Mastectomy and Immediate Breast Reconstruction with Gel Implant. Plast Reconstr Surg Glob Open. 2018 Jun 11;6(6):e1828. doi: 10.1097/GOX.0000000000001828. eCollection 2018 Jun.
Lai HW. Robotic Nipple-Sparing Mastectomy and Immediate Breast Reconstruction with Gel Implant. Ann Surg Oncol. 2019 Jan;26(1):53-54. doi: 10.1245/s10434-018-6711-3. Epub 2018 Aug 25. No abstract available.
Lai HW, Lin SL, Chen ST, Lin YL, Chen DR, Pai SS, Kuo SJ. Robotic nipple sparing mastectomy and immediate breast reconstruction with robotic latissimus dorsi flap harvest - Technique and preliminary results. J Plast Reconstr Aesthet Surg. 2018 Oct;71(10):e59-e61. doi: 10.1016/j.bjps.2018.07.006. Epub 2018 Aug 2. No abstract available.
Lai HW, Chen ST, Lin SL, Chen CJ, Lin YL, Pai SH, Chen DR, Kuo SJ. Robotic Nipple-Sparing Mastectomy and Immediate Breast Reconstruction with Gel Implant: Technique, Preliminary Results and Patient-Reported Cosmetic Outcome. Ann Surg Oncol. 2019 Jan;26(1):42-52. doi: 10.1245/s10434-018-6704-2. Epub 2018 Aug 14.
Lai HW, Chen ST, Lin SL, Lin YL, Wu HK, Pai SH, Chen DR, Kuo SJ. Technique for single axillary incision robotic assisted quadrantectomy and immediate partial breast reconstruction with robotic latissimus dorsi flap harvest for breast cancer: A case report. Medicine (Baltimore). 2018 Jul;97(27):e11373. doi: 10.1097/MD.0000000000011373.
Sarfati B, Struk S, Leymarie N, Honart JF, Alkhashnam H, Tran de Fremicourt K, Conversano A, Rimareix F, Simon M, Michiels S, Kolb F. Robotic Prophylactic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: A Prospective Study. Ann Surg Oncol. 2018 Sep;25(9):2579-2586. doi: 10.1245/s10434-018-6555-x. Epub 2018 Jun 29.
Sarfati B, Struk S, Leymarie N, Honart JF, Alkhashnam H, Kolb F, Rimareix F. Robotic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: Surgical Technique. Plast Reconstr Surg. 2018 Sep;142(3):624-627. doi: 10.1097/PRS.0000000000004703.
Sarfati B, Honart JF, Leymarie N, Rimareix F, Al Khashnam H, Kolb F. Robotic da Vinci Xi-assisted nipple-sparing mastectomy: First clinical report. Breast J. 2018 May;24(3):373-376. doi: 10.1111/tbj.12937. Epub 2017 Dec 18.
Sarfati B, Honart JF, Leymarie N, Kolb F, Rimareix F. Robotic-assisted Nipple Sparing Mastectomy: A feasibility study on cadaveric models. J Plast Reconstr Aesthet Surg. 2016 Nov;69(11):1571-1572. doi: 10.1016/j.bjps.2016.08.007. Epub 2016 Sep 8. No abstract available.
Park HS, Lee J, Lai HW, Park JM, Ryu JM, Lee JE, Kim JY, Marrazzo E, De Scalzi AM, Corso G, Montemurro F, Gazzetta G, Pozzi G, Toesca A. Surgical and Oncologic Outcomes of Robotic and Conventional Nipple-Sparing Mastectomy with Immediate Reconstruction: International Multicenter Pooled Data Analysis. Ann Surg Oncol. 2022 Oct;29(11):6646-6657. doi: 10.1245/s10434-022-11865-x. Epub 2022 May 18.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4-2019-0834
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.