NCT04108117|Completed
Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction
SORI
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SORI
Sponsor study identifier
observational
659
1 country
1
Study Start
May 14, 2020
Actual (reported)Primary Completion
May 4, 2022
Actual (reported)Study Completion
May 18, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 18, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 26, 2019
Actual (reported)September 27, 2019
Actual (reported)May 14, 2020
Actual (reported)May 4, 2022
Actual (reported)May 18, 2022
Actual (reported)Postoperative complication rates in 30 days
Postoperative complication rates are calculated as total number of postoperative complication cases per total operation cases.
Postoperative 30 days
Clavien-Dindo grade of postoperative complications
Clavien-Dindo grade of postoperative complications is evaluated. The highest grade of postoperative complications are used for the analysis.
Postoperative 30 days
Nipple necrosis rates
Nipple necrosis rates are calculated as number of total nipple necrosis cases per total operation cases.
Postoperative 30 days
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.
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.
Robotic nipple sparing mastectomy means nipple sparing mastectomy performed using robotic surgical systems.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients who underwent nipple-sparing mastectomy between 2016 and 2020 at Severance Hospital, Seoul, Korea. Patients who underwent nipple-sparing mastectomy between 2016 and 2020 at Samsung Medical Center, Seoul, Korea. Patients who underwent nipple sparing mastectomy between 2014 and 2019 at European Institute of Oncology, Milan, Italy. Patients who underwent nipple-sparing mastectomy between 2017 and 2019 at Changhua Christian Hospital, Changhua City, Taiwan. Patients who underwent nipple-sparing mastectomy between 2015 and 2019 at Gustave Roussy, Paris, France.
Yonsei University College of Medicine
Seoul, 120-752, South Korea
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.
Hyung Seok Park, MD, PhD
Severance Hospital
Antonio Toesca, MD
European Institute of Oncology
659 participants (actual enrollment reported by the registry).
First Submitted
September 26, 2019
First Posted
September 27, 2019
Study Start
May 14, 2020
Actual (reported)Pilot Study of Single-port Robot-assisted Nipple-sparing Mastectomy
Recurrence free survival (RFS)
Events of RFS includes locoregional recurrence, distant recurrence, and death. Contralateral breast cancer and second primary malignancy are considered to be censored data.
Postoperative 5 years
Operation times
Time during operation
Locoregional recurrence-free survival (LRFS)
Postoperative 5 years
Contact the study team to confirm eligibility.
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.
Primary Completion
May 4, 2022
Actual (reported)Study Completion
May 18, 2022
Actual (reported)Last Updated
September 11, 2023
Record last verified: 2023-09
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