Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery (MARRES)
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|ClinicalTrials.gov Identifier: NCT04585074|
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : June 8, 2021
|Condition or disease||Intervention/treatment|
|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)|
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 Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Prospective Cohort Study of Mastectomy With Reconstruction Including Robot Endoscopic Breast Surgery|
|Actual Study Start Date :||April 8, 2020|
|Estimated Primary Completion Date :||April 7, 2025|
|Estimated Study Completion Date :||April 7, 2030|
- 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.Other Names:
- Robot-assisted nipple sparing mastectomy
- Robot mastectomy
- Robotic mastectomy
- Hybrid robotic nipple sparing mastectomy
- Robot-assisted nipple areolar complex and skin sparing mastectomy
- Endoscopic nipple sparing mastectomy
- Procedure: 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.Other Names:
- Total mastectomy
- Nipple-sparing mastectomy
- Skin sparing mastectomy
- Postoperative complication rates in 30 days [ Time Frame: 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 [ Time Frame: Postoperative 180 days ]Clavien-Dindo grade of postoperative complications is evaluated. The highest grade of postoperative complications are used for the analysis.
- Recurrence free survival (RFS) [ Time Frame: 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 [ Time Frame: Postoperative 5 years ]cancer incidence rate for those underwent prophylactic mastectomy
- Patient's satisfaction (about reconstruction expectations) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04585074
|Contact: Hyung Seok Park, MD, PhDemail@example.com|
|Korea, Republic of|
|Yonsei University College of Medicine||Recruiting|
|Seoul, Korea, Republic of, 120-752|
|Contact: Hyung Seok Park, MD, PhD +82-2228-2100 firstname.lastname@example.org|
|Principal Investigator:||Hyung Seok Park, MD, PhD||Severance Hospital|