Postoperative ComplicationsSORINCT04108117
Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction
An observational study of Postoperative Complications and Recurrence, run by Severance Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications, Recurrence, Breast Neoplasms
- What is being tested?
- Robotic nipple sparing mastectomy
- Type of treatment
- Surgery or procedure
- How many people
- 659 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 May 2020to 18 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction : an International Multicenter Pooled Analysis
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.
Read the 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 reconstruction.
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
- Postoperative Complications, Recurrence, Breast Neoplasms, Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Being tested
- Robotic nipple sparing mastectomy
- Keywords
- Robotic mastectomy, Breast neoplasms, Postoperative complications, Recurrence, Prognosis, Survivals, Nipple sparing mastectomy, Immediate reconstruction
- Medical subject headings
- Postoperative Complications, Recurrence, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic nipple sparing mastectomyProcedure or surgery
Also called Robot-assisted nipple sparing mastectomy, Robot mastectomy, Robotic mastectomy, Hybrid robotic nipple sparing mastectomy
Robotic nipple sparing mastectomy means nipple sparing mastectomy performed using robotic surgical systems.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Robotic nipple sparing mastectomy | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complication rates in 30 days
Postoperative complication rates are calculated as total number of postoperative complication cases per total operation cases.
Measured: 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.
Measured: Postoperative 30 days
Nipple necrosis rates
Nipple necrosis rates are calculated as number of total nipple necrosis cases per total operation cases.
Measured: Postoperative 30 days
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.
Measured: Postoperative 5 years
Secondary outcomes (2)
Operation times
Mastectomy time or reconstruction time
Measured: Time during operation
Locoregional recurrence-free survival (LRFS)
In breast tumor recurrences (IBTR), regional recurrences including axillary, internal mammary, or supraclavicular lymph node recurrences, and death without any cause are events of locoregional recurrence-free survival. Five year LRFS is measured. Distant metastasis, contralateral breast cancer and second primary malignancy are considered to be censored data.
Measured: Postoperative 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start14 May 2020
- Primary completion4 May 2022
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- European Institute of Oncology, Changhua Christian Hospital, Samsung Medical Center
- Responsible party
- Principal investigator, Hyung Seok Park, MD, PhD, Severance Hospital
- Investigators
- Hyung Seok Park, MD, PhD, Principal investigator, Severance HospitalAntonio Toesca, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108117
- Sponsor's protocol ID
- 4-2019-0834
- Acronym
- SORI
- Status last verified
- Sep 2023
- First submitted
- 26 Sep 2019
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After completion of this study, IPD can be considered based on the decision of the study steering comittee.
Publications
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.
PubMed 27810700Park 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.
PubMed 30275863Galimberti 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.
PubMed 30225833Toesca 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.
PubMed 28692558Toesca 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.
PubMed 28153430Lai 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.
PubMed 30360987Lai 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.
PubMed 30276055Lai 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.
PubMed 30145648Lai 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.
PubMed 30122600Lai 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.
PubMed 30109537Lai 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.
PubMed 29979425Sarfati 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.
PubMed 29959612Sarfati 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.
PubMed 29879007Sarfati 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.
PubMed 29251382Sarfati 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.
PubMed 27665275
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction : an International Multicenter Pooled Analysis
- ClinicalTrials.gov ID
- NCT04108117
- Acronym / sponsor ID
- SORI / 4-2019-0834
- Conditions
- Postoperative Complications, Recurrence, Breast Neoplasms, Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Keywords
- Robotic mastectomy, Breast neoplasms, Postoperative complications, Recurrence, Prognosis, Survivals, Nipple sparing mastectomy, Immediate reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 659 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Collaborators
- European Institute of Oncology, Changhua Christian Hospital, Samsung Medical Center
- Study start
- 14 May 2020 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 reconstruction.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic nipple sparing mastectomy group/RNSM | – | Procedure: Robotic nipple sparing mastectomyCases 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. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic nipple sparing mastectomyAlso: Robot-assisted nipple sparing mastectomy, Robot mastectomy, Robotic mastectomy, Hybrid robotic nipple sparing mastectomyRobotic nipple sparing mastectomy means nipple sparing mastectomy performed using robotic surgical systems. | Procedure or surgery | Robotic nipple sparing mastectomy group/RNSM |
Primary outcome
Postoperative complication rates in 30 days
Time frame: Postoperative 30 days
Postoperative complication rates are calculated as total number of postoperative complication cases per total operation cases.
Clavien-Dindo grade of postoperative complications
Time frame: Postoperative 30 days
Clavien-Dindo grade of postoperative complications is evaluated. The highest grade of postoperative complications are used for the analysis.
Nipple necrosis rates
Time frame: Postoperative 30 days
Nipple necrosis rates are calculated as number of total nipple necrosis cases per total operation cases.
Recurrence free survival (RFS)
Time frame: Postoperative 5 years
Events of RFS includes locoregional recurrence, distant recurrence, and death. Contralateral breast cancer and second primary malignancy are considered to be censored data.
2 secondary outcomes
Operation times
Time frame: Time during operation
Locoregional recurrence-free survival (LRFS)
Time frame: Postoperative 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Background: PubMed 27810700Toesca 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.
- Background: PubMed 30275863Park 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.
- Background: PubMed 30225833Galimberti 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.
- Background: PubMed 28692558Toesca 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.
- Background: PubMed 28153430Toesca 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.
- Background: PubMed 30360987Lai 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.
- Background: PubMed 30276055Lai 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.
- Background: PubMed 30145648Lai 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.
- Background: PubMed 30122600Lai 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.
- Background: PubMed 30109537Lai 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.
- Background: PubMed 29979425Lai 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.
- Background: PubMed 29959612Sarfati 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.
- Individual participant dataSharing planned: Undecided. After completion of this study, IPD can be considered based on the decision of the study steering comittee.
Related trials for Postoperative Complications
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyung Seok Park, MD, PhD principal investigator
Severance Hospital
Antonio Toesca, MD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Recurrence, run by Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complication rates in 30 days (time frame: Postoperative 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04108117, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.