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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
Sponsor:
Collaborators:
Samsung Medical Center
Kyungpook National University Chilgok Hospital
Asan Medical Center
Information provided by (Responsible Party):
Hyung Seok Park, MD, PhD, Severance Hospital

Study Description
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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
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
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Study Type : Observational
Estimated 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 : April 8, 2020
Estimated Primary Completion Date : April 7, 2025
Estimated Study Completion Date : April 7, 2030

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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
    • Mastectomy
    • Nipple-sparing mastectomy
    • Skin sparing mastectomy

Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Cancer incidence rate [ Time Frame: Postoperative 5 years ]
    cancer incidence rate for those underwent prophylactic mastectomy

  3. 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.

  4. Patient's satisfaction (about reconstruction results) [ Time Frame: within preoperative 4 weeks to operation and within postoperative 6 month to 12 month. ]
    1. Mastectomy Module Pre-and Postoperative Scales Satisfaction with Breasts as assessed by BREAST-Q version 2.0. Higher scores reflect a better outcome.
    2. 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.

  5. 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.

  6. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent nipple-sparing mastectomy between 2020 and 2023 at Severance Hospital, Seoul, Korea
Criteria

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

Exclusion Criteria:

  • Patients scheduled for breast conserving mastectomy
  • Patients who do not want immediate reconstruction during mastectomy
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Hyung Seok Park, MD, PhD +82-2-2228-2100 imgenius@yuhs.ac

Locations
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Korea, Republic of
Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Hyung Seok Park, MD, PhD    +82-2228-2100    imgenius@yuhs.ac   
Sponsors and Collaborators
Severance Hospital
Samsung Medical Center
Kyungpook National University Chilgok Hospital
Asan Medical Center
Investigators
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Principal Investigator: Hyung Seok Park, MD, PhD Severance Hospital
More Information
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Responsible Party: Hyung Seok Park, MD, PhD, Associate Professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT04585074    
Other Study ID Numbers: 4-2020-0165
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hyung Seok Park, MD, PhD, Severance Hospital:
minimal invasive procedure
robot assisted nipple sparing mastectomy
breast immediate reconstruction
breast neoplasms
Additional relevant MeSH terms:
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Breast Neoplasms
Breast Diseases
Fibrocystic Breast Disease
 Neoplasms
Neoplasms by Site
Skin Diseases