Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery

Summary

Participation Requirements

Description

This study is a multi-institution cohort study that prospectively collects patients undergoing mastectomy and reconstruction. Patients' inclusion criteria is as below; adult women over the age of 19, with breast cancer or high risk of breast cancer (patients with a BRCA1/2 mutation, TP53 mutation, P...

This study is a multi-institution cohort study that prospectively collects patients undergoing mastectomy and reconstruction. Patients' inclusion criteria is as below; adult women over the age of 19, 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. 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 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 3rd year after the start of the study and collecting data. Complete the follow-up observation and data collection of the subjects recruited in the 4-8 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.

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