Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery

Study Results

Results pending

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.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-08

Study Completion Date

2030-04-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction

NCT05490433

Breast Cancer Classified as TNM Stage 0-IIIa

RECRUITING NA

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

NCT04108117

Postoperative Complications Recurrence Breast Neoplasms +5 more

COMPLETED

Surgical and Patient Reported Outcomes in Robotic Mastectomy

NCT06335550

Breast Cancer

COMPLETED NA

Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction

NCT05945914

Breast Cancer Breast Reconstruction

COMPLETED

To Evaluate the Effectiveness and Safety of Mastectomy Combined With Immediate Breast Reconstruction in Breast Cancer

NCT06817954

Breast Cancer

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasms Germline BRCA1 Gene Mutation Germline BRCA2 Gene Mutation Benign Breast Disease Germline Mutation Abnormality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Robotic or endoscopic nipple sparing mastectomy

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.

Intervention Type PROCEDURE

Conventional mastectomy (including nipple sparing mastectomy, skin 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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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 Total mastectomy Mastectomy Nipple-sparing mastectomy Skin sparing mastectomy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female patient between the ages of 19 and 80
* Patients with breast cancer or high risk of breast cancer ( BRCA1/2 mutation, TP53 mutation, PALB2, etc.)
* Patients scheduled for therapeutic or prophylactic mastectomy (including conventional mastectomy, skin sparing mastectomy, areolar conserving mastectomy)
* Patients who want immediate reconstruction during mastectomy
* Those agreed in writing consent to participate study

Exclusion Criteria

* Patients scheduled for breast conserving mastectomy
* Patients who do not want immediate reconstruction during mastectomy
* Patients who planned for surgery on both sides in the different methods

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No