Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery

Breast Neoplasms Clinical Trial

— MARRES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04585074
• Other study ID #: 4-2020-0165
• Status: Recruiting
• Start date: April 8, 2020
• Est. completion date: April 7, 2030

Study information

• Verified date: February 2024
• Source: Severance Hospital
• Contact: Hyung Seok Park, MD, PhD
• Phone: +82-2-2228-2100
• Email: imgenius[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: April 7, 2030
• Est. primary completion date: April 7, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan	Gyeonggi-do
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Samsung Changwon Medical Center	Changwon	Gyeongsangnam-do
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Myongji Hospital	Goyang	Gyeonggi-do
Korea, Republic of	The Catholic University of Korea, Incheon ST. Mary's Hospital	Incheon
Korea, Republic of	Chungnam National University Sejong Hospital	Sejong	Chungcheongnam-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Soonchunhyang University Hospital	Seoul
Korea, Republic of	Yonsei University College of Medicine	Seoul
Korea, Republic of	Wonju Severance Christian hospital	Wonju	Gangwon-do
Korea, Republic of	Yongin Severance Hospital	Yongin-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Cancer incidence rate	cancer incidence rate for those underwent prophylactic mastectomy	Postoperative 5 years
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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