Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery (MARRES)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasms; Benign Breast Disease; Germline BRCA1 Gene Mutation; Germline BRCA2 Gene Mutation; Germline Mutation Abnormality
• Intervention / Treatment: 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 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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Hyung Seok Park, MD, PhD; Phone Number: +82-2-2228-2100; Email: imgenius@yuhs.ac

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 49267
    • Recruiting
    • Kosin University Gospel Hospital
    • Contact: Gusang Kim, MD,PhD
  • Daegu, Korea, Republic of, 41404
    • Recruiting
    • Kyungpook National University Chilgok Hospital
    • Contact: Jeeyeon Lee, MD, PhD
  • Incheon, Korea, Republic of, 21431
    • Recruiting
    • The Catholic University of Korea, Incheon St. Mary's Hospital
    • Contact: Young Joon Kang, MD, PhD
  • Seoul, Korea, Republic of, 08308
    • Recruiting
    • Korea University Guro Hospital
    • Contact: Sanguk Woo, MD
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Honggyu Kim, MD, PhD
  • Seoul, Korea, Republic of, 06273
    • Recruiting
    • Gangnam Severance Hospital
    • Contact: Sungjun Bae, MD,PhD
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Samsung Medical Center
    • Contact: Jai Min Ryu, MD, PhD
  • Seoul, Korea, Republic of, 04401
    • Recruiting
    • Soonchunhyang University Hospital
    • Contact: Jun-Hee Lee, MD, PhD
  • Seoul, Korea, Republic of, 138-736
    • Recruiting
    • Asan Medical Center
    • Contact: Sae Byeol Lee, MD, PhD
  • Seoul, Korea, Republic of, 02841
    • Recruiting
    • Korea University Anam Hospital
    • Contact: Ji Young You, MD, PhD
  • Seoul, Korea, Republic of, 07061
    • Recruiting
    • Seoul Metropolitan Government Seoul National University Boramae Medical Center
    • Contact: Jong-Ho Cheun, MD
  • Seoul, Korea, Republic of, 120-752
    • Recruiting
    • Yonsei University College of Medicine
    • Contact: Hyung Seok Park, MD, PhD; Phone Number: +82-2228-2100; Email: imgenius@yuhs.ac
  • Chungcheongnam-do
    • Sejong, Chungcheongnam-do, Korea, Republic of, 30099
      • Recruiting
      • Chungnam National University Sejong Hospital
      • Contact: Younju Lee, MD, PhD
  • Gangwon-do
    • Wonju, Gangwon-do, Korea, Republic of, 26426
      • Recruiting
      • Wonju Severance Christian Hospital
      • Contact: Aeri Han, MD, PhD
  • Gyeonggi-do
    • Ansan, Gyeonggi-do, Korea, Republic of, 15355
      • Recruiting
      • Korea University Ansan Hospital
      • Contact: Yeongwoo chang, MD, PhD
    • Goyang, Gyeonggi-do, Korea, Republic of, 10475
      • Recruiting
      • Myongji Hospital
      • Contact: Hyukjai Shin, MD, PhD
    • Yongin-si, Gyeonggi-do, Korea, Republic of, 16995
      • Recruiting
      • Yongin Severance Hospital
      • Contact: Joo Heung Kim, MD
  • Gyeongsangnam-do
    • Changwon, Gyeongsangnam-do, Korea, Republic of, 51353
      • Recruiting
      • Samsung Changwon Medical Center
      • Contact: Hee Jun Choi, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent nipple-sparing mastectomy between 2020 and 2024 at Severance Hospital, Seoul, Korea

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complication rates in 30 days	Postoperative complication rates are calculated as total number of postoperative complication cases per total operation cases.	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.	Postoperative 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postoperative 5 years
Cancer incidence rate	cancer incidence rate for those underwent prophylactic mastectomy	Postoperative 5 years
Patient's satisfaction (about reconstruction expectations)	Reconstruction Expectations of Preoperative Short Form. In all scales, higher scores reflect a better outcome.	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)	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.	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.	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.	Postoperative 6 month to 1 year(Patients who have undergone skin sparing mastectomy can do within up to 3 years

Collaborators and Investigators

• Sponsor: Severance Hospital
• Collaborators: Samsung Medical Center; Asan Medical Center; Kyungpook National University Chilgok Hospital
• Investigators: Principal Investigator: Hyung Seok Park, MD, PhD, Severance Hospital

Publications and helpful links

General Publications

• Ryu JM, Lee J, Lee J, Ko B, Kim JH, Shin H, Park HS; Korea Robot-endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG). Mastectomy with Reconstruction Including Robotic Endoscopic Surgery (MARRES): a prospective cohort study of the Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG) and Korean Breast Cancer Study Group (KBCSG). BMC Cancer. 2023 Jun 21;23(1):571. doi: 10.1186/s12885-023-10978-0.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2020
• Primary Completion (Estimated): April 7, 2025
• Study Completion (Estimated): April 7, 2030

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: October 10, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: breast neoplasms; minimal invasive procedure; robot assisted nipple sparing mastectomy; breast immediate reconstruction
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Neoplasms; Breast Diseases; Fibrocystic Breast Disease
• Other Study ID Numbers: 4-2020-0165

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No