Clinical trial NCT04585074: Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery
Official title: Prospective Cohort Study of Mastectomy With Reconstruction Including Robot Endoscopic Breast Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Neoplasms
Germline BRCA1 Gene Mutation
Germline BRCA2 Gene Mutation
Benign Breast Disease
Germline Mutation Abnormality
Keywords: minimal invasive procedure
robot assisted nipple sparing mastectomy
breast immediate reconstruction
breast neoplasms
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent nipple-sparing mastectomy between 2020 and 2024 at Severance Hospital, Seoul, Korea

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative complication rates in 30 days
timeFrame: Postoperative 30 days
measure: Clavien-Dindo grade of postoperative complications
timeFrame: Postoperative 180 days
Secondary outcomes:
measure: Recurrence free survival (RFS)
timeFrame: Postoperative 5 years
measure: Cancer incidence rate
timeFrame: Postoperative 5 years
measure: Patient's satisfaction (about reconstruction expectations)
timeFrame: 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)
measure: Patient's satisfaction (about reconstruction results)
timeFrame: 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)
measure: Surgeon's satisfaction
timeFrame: Postoperative 6 month to 12 month(Patients who have undergone skin sparing mastectomy can do within up to 3 years
measure: Cost-effectiveness
timeFrame: Postoperative 6 month to 1 year(Patients who have undergone skin sparing mastectomy can do within up to 3 years
Other outcomes:
Locations:
city: Sejong
country: Korea, Republic of
facility: Chungnam National University Sejong Hospital
state: Chungcheongnam-do
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian hospital
state: Gangwon-do
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital
state: Gyeonggi-do
city: Yongin-si
country: Korea, Republic of
facility: Yongin Severance Hospital
state: Gyeonggi-do
city: Changwon
country: Korea, Republic of
facility: Samsung Changwon Medical Center
state: Gyeongsangnam-do
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Severance Hospital
name: Hyung Seok Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banfield S. A management systems analysis. Caring. 1987 Jul;6(7):45-50. No abstract available.