MARRES: Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery

Sponsor

Severance Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04585074

Collaborator

Samsung Medical Center (Other), Kyungpook National University Chilgok Hospital (Other), Asan Medical Center (Other)

2,000

Enrollment

Location

120

Anticipated Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Robotic mastectomy and immediate reconstruction have been introduced recently in 2015. However, since robotic mastectomy is latest surgical technique, there is a lack of studies comparing conventional mastectomy and immediate reconstruction with robotic mastectomy prospectively. For this reason, this study is designed to establish a single institution cohort study that prospectively collects patients undergoing mastectomy and reconstruction. And 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms Germline BRCA1 Gene Mutation Germline BRCA2 Gene Mutation Benign Breast Disease Germline Mutation Abnormality	Procedure: Robotic or endoscopic nipple sparing mastectomy Procedure: Conventional mastectomy (including nipple sparing mastectomy, skin sparing mastectomy)

Detailed 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, 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Cohort Study of Mastectomy With Reconstruction Including Robot Endoscopic Breast Surgery

Actual Study Start Date :

Apr 8, 2020

Anticipated Primary Completion Date :

Apr 7, 2025

Anticipated Study Completion Date :

Apr 7, 2030

Outcome Measures

Primary Outcome Measures

Postoperative complication rates in 30 days [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 [Postoperative 180 days]
Clavien-Dindo grade of postoperative complications is evaluated. The highest grade of postoperative complications are used for the analysis.

Secondary Outcome Measures

Recurrence free survival (RFS) [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.
Cancer incidence rate [Postoperative 5 years]
cancer incidence rate for those underwent prophylactic mastectomy
Patient's satisfaction (about reconstruction expectations) [within preoperative 4 weeks to operation and within postoperative 6 month to 12 month.]
Reconstruction Expectations of Preoperative Short Form. In all scales, higher scores reflect a better outcome.
Patient's satisfaction (about reconstruction results) [within preoperative 4 weeks to operation and within postoperative 6 month to 12 month.]
Mastectomy Module Pre-and Postoperative Scales Satisfaction with Breasts as assessed by BREAST-Q version 2.0. Higher scores reflect a better outcome. 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.
Surgeon's satisfaction [Postoperative 6 month]
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.
Cost-effectiveness [Postoperative 6 month to 1 year]
Cost-effectiveness evaluation according to the surgical method, by conducting a questionnaire survey on the subject 6 months to 1 year after the last surgery. Evaluation follows the EuroQol five-dimension scale(EQ5D) Korean version questionnaire. In all scales, higher scores reflect a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Female patient over the age of 19
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