A Prospective Multicenter Randomized Clinical Trial: Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction (ROM) Trial

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Research Purpose The present study is designed to generate the strongest evidence available on the role of robotic surgical systems in breast cancer surgery and to elucidate the clinical value of immediate breast reconstruction (IBR) conducted in conjunction with robot-assisted nipple-sparing mastectomy (RNSM). Study Design Overview This study is a prospective, multicenter, randomized clinical trial (ROM Trial) designed to compare the oncologic outcomes of robot-assisted nipple-sparing mastectomy (RNSM) with conventional nipple-sparing mastectomy (CNSM), which includes both traditional and open-chest approaches. Previous retrospective studies of robot-assisted endoscopic surgery have suggested a short learning curve, demonstrating technical feasibility and reproducibility even for less experienced surgeons. However, the absence of rigorously designed randomized clinical trials remains a major global barrier to the broader adoption of robotic breast surgery. In the ROM Trial, eligible patients who provide written informed consent will be randomly assigned in a 1:1 ratio to undergo either RNSM or CNSM. Participants will be blinded to group allocation until the day of surgery (single-blind design). Immediate breast reconstruction (IBR) will be performed in all patients, with the reconstruction method determined in consultation with the breast and/or plastic surgeon following mastectomy.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 19
Maximum Age: 70
Healthy Volunteers: f
View:

• Adult women (≥19 years) scheduled to undergo therapeutic mastectomy for breast cancer who desire immediate breast reconstruction (IBR).

• Breast cancer classified as clinical TNM stage 0 to IIIA, based on preoperative evaluation according to the 8th edition of the AJCC anatomic staging system.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Locations
Other Locations
Republic of Korea
Samsung Changwon Medical Center
NOT_YET_RECRUITING
Changwon
Keimyung University Dongsan Hospital
NOT_YET_RECRUITING
Daegu
Kyungpook National University Chilgok Hospital
NOT_YET_RECRUITING
Daegu
Myongji Hospital
NOT_YET_RECRUITING
Goyang-si
The Catholic University of Korea, Incheon ST. Mary's Hospital
NOT_YET_RECRUITING
Incheon
Kosin University Gospel Hospital
NOT_YET_RECRUITING
Pusan
Chungnam National University Sejong Hospital
NOT_YET_RECRUITING
Sejong
Asan Medical Center
NOT_YET_RECRUITING
Seoul
Gangnam Severance Hospital
NOT_YET_RECRUITING
Seoul
Korea University Anam Hospital
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Yonsei University Health System, Severance Hospital
RECRUITING
Seoul
Yongin Severance Hospital
NOT_YET_RECRUITING
Yongin-si
Contact Information
Primary
Hyung Seok Park, MD, PhD
imgenius@yuhs.ac
82-10-6760-2974
Time Frame
Start Date: 2022-10-26
Estimated Completion Date: 2032-06
Participants
Target number of participants: 790
Treatments
Experimental: robot assisted nipple sparing mastectomy(RNSM)
Robotic nipple sparing mastectomy, robotic mastectomy, hybrid robotic nipple sparing mastectomy, robotic nipple mammary complex and skin sparing mastectomy, robot nipple sparing mastectomy
Active_comparator: Conventional nipple sparing mastectomy(CNSM)
Total mastectomy, mastectomy, nipple sparing mastectomy, skin sparing mastectomy, nipple sparing breast resection, open nipple sparing mastectomy, general nipple sparing Mammastectomy, an open-window nipple sparing mastectomy
Related Therapeutic Areas
Sponsors
Leads: Yonsei University

This content was sourced from clinicaltrials.gov