Breast Neoplasms Clinical Trial
— MARRESOfficial title:
Prospective Cohort Study of Mastectomy With Reconstruction Including Robot Endoscopic Breast Surgery
NCT number | NCT04585074 |
Other study ID # | 4-2020-0165 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 8, 2020 |
Est. completion date | April 7, 2030 |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Severance Hospital |
Korea, Republic of,
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
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 |
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