An observational study in Breast Neoplasms, Germline BRCA1 Gene Mutation and Germline BRCA2 Gene Mutation, sponsored by Severance Hospital. Active, not recruiting at 18 sites in Korea, Republic of. Open to female participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Severance Hospital · Observational
Robotic mastectomy and immediate reconstruction have been introduced in 2015. However, since robotic mastectomy is the latest surgical technique, there is a lack of studies prospectively comparing conventional mastectomy and immediate reconstruction with robotic mastectomy. For this reason, this study is designed to establish a single institution cohort study that prospectively collects patients undergoing mastectomy and reconstruction. This study was initially designed as a single institution study, however, currently, the study was extended to the multicenter study including 18 institutions over the country. Using the established prospective cohort data, a comparative study of robotic mastectomy with conventional mastectomy and reconstruction, and cost-effectiveness and satisfaction of robotic endoscopic surgery, and cost-effectiveness and satisfaction of reconstructive surgery are to be analyzed.
This study is a multi-institution cohort study that prospectively collects patients undergoing mastectomy and reconstruction.
Patients' inclusion criteria is as below; adult women between the ages of 19 and 80, with breast cancer or high risk of breast cancer (patients with a BRCA1/2 mutation, TP53 mutation, PALB2 mutation, etc) scheduled for therapeutic or prophylactic mastectomy, and want immediate reconstruction.
Patients planned for breast-conserving surgery or who do not want immediate reconstruction will be excluded. Patients who planned for surgery on both sides in the different methods (e.g. right for RNSM and left for conventional open NSM) are also excluded. Meanwhile, cases with ipsilateral NSM and contralateral partial mastectomy or excision are included.
The goal number of enrolled patients is 2000.
Collecting data includes patients' clinicopathological factors including height, weight, etc. And also collecting surgical results, oncological results, cost-effectiveness, and satisfactions of patients to secure high-level data.
The satisfaction of patients using the Breast Q survey, basic characteristics like height, weight, etc, and patients' photos will be collected preoperatively.
Also, patients' data will be collected within 6 months after surgery including clinical-pathological factors, surgery results (drainage amount, removal date, complications), postoperative recovery evaluation, complications and adverse reactions, cost, etc.
Between 6 months and 1 year(Patients who have undergone skin sparing mastectomy can do within up to 3 years) after surgery, the results of surgery, recurrence, satisfaction survey, and postoperative photos will be collected.
Every 12 months thereafter, whether adjuvant therapy (chemotherapy, radiation therapy, targeted therapy, endocrine therapy) was implemented, surgical results, and recurrence will be investigated and collected until the end of the study period.
An interim analysis will be done after completing the recruitment of subjects by the 4th year after the start of the study and collecting data. Complete the follow-up observation and data collection of the subjects recruited in the 5-9 years and the final analysis will be conducted.
Categorial variables will be examined by the chi-square test or Fisher's exact test.
Continuous variables will be examined by t-test or ANOVA, and M-W test or K-W test if needed.
Survival analysis will be examined by Kaplan-Meier plot and log-rank test.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Severance Hospital is the lead sponsor of 51 studies on the registry; 3 are open to participants now.
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Patients who underwent nipple-sparing mastectomy between 2020 and 2024 at Severance Hospital, Seoul, Korea
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Exclusion Criteria:
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.
Also known as: Robot-assisted nipple sparing mastectomy, Robot mastectomy, Robotic mastectomy, Hybrid robotic nipple sparing mastectomy, Robot-assisted nipple areolar complex and skin sparing mastectomy, Endoscopic nipple sparing mastectomy
Cases or Patients who underwent conventional mastectomy and immediate reconstruction are enrolled in this arm. Conventional mastectomy should not be performed using robotic or endoscopic surgical systems. Any incisions can be performed for this procedure. Conventional mastectomy includes also Nipple-sparing mastectomy and Skin sparing mastectomy. Immediate reconstruction includes tissue expander insertion, direct-to-implant, latissimus dorsi flap, transverse abdominis rectus muscle flap, or deep inferior epigastric perforators flap. Cases without immediate reconstruction are excluded.
Also known as: Total mastectomy, Mastectomy, Nipple-sparing mastectomy, Skin sparing mastectomy
Postoperative complication rates in 30 days
Postoperative complication rates are calculated as total number of postoperative complication cases per total operation cases.
Time frame: 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.
Time frame: Postoperative 180 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.
Time frame: Postoperative 5 years
Cancer incidence rate
cancer incidence rate for those underwent prophylactic mastectomy
Time frame: Postoperative 5 years
Patient's satisfaction (about reconstruction expectations)
Reconstruction Expectations of Preoperative Short Form. In all scales, higher scores reflect a better outcome.
Time frame: within preoperative 4 weeks to operation and within postoperative 6 month to 12 month.(Patients who have undergone skin sparing mastectomy can do within up to 3 years)
Patient's satisfaction (about reconstruction results)
1. Mastectomy Module Pre-and Postoperative Scales Satisfaction with Breasts as assessed by BREAST-Q version 2.0. Higher scores reflect a better outcome. 2. Reconstruction Module Pre-and Postoperative Scales Satisfaction with abdomen as assessed by BREAST-Q version 2.0 (This scale should only be completed by the patient who has had reconstruction using a transverse rectus abdominis myocutaneous flap(TRAM flap) or deep inferior epigastric perforators flap(DIEP flap). Otherwise, skip it.) Satisfaction with Back as assessed by BREAST-Q version 2.0 (This scale should only be completed by the patient who has had reconstruction using a latissimus dorsi flap. Otherwise, skip it.) Satisfaction with Implants as assessed by BREAST-Q version 2.0 (This scale should only be completed by the patient who has had reconstruction using implants. Otherwise, skip it.) In all scales, higher scores reflect a better outcome.
Time frame: within preoperative 4 weeks to operation and within postoperative 6 month to 12 month.(Patients who have undergone skin sparing mastectomy can do within up to 3 years)
Surgeon's satisfaction
Satisfaction of Surgery assessed by (Plastic)Surgeon(s) Items(1), Response Options(Overall symmetry, postoperative scar, nipple areolar complex symmetry, etc), Range(0-10) The higher scores are, the better an outcome is.
Time frame: Postoperative 6 month to 12 month(Patients who have undergone skin sparing mastectomy can do within up to 3 years
Cost-effectiveness
Cost-effectiveness evaluation according to the surgical method, by conducting a questionnaire survey on the subject 6 months to 1 year(Patients who have undergone skin sparing mastectomy up to 3 years) after the last surgery. Evaluation follows the EuroQol five-dimension scale(EQ5D, EQ5D-5L) Korean version questionnaire. In all scales, higher scores reflect a better outcome.
Time frame: Postoperative 6 month to 1 year(Patients who have undergone skin sparing mastectomy can do within up to 3 years
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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