“The psychosocial benefits of RNSM for the patient are obvious,” Dr. Park says. “My goal is to perform these robot-assisted surgeries and collect the data required to support eventual approval and widespread use of the technique here in the U.S. It’s already being performed in Canada, as well as multiple European and Asian countries.
“A breast cancer diagnosis can be overwhelming,” she adds. “Anything we can do to improve cosmetic appearance while maintaining or improving outcomes is a huge step forward in helping patients thrive after that initial diagnosis.”
The traditional open surgery used for most mastectomies can prove technically challenging. Although the robot doesn't represent new technology, its use for NSM is novel. Supported by a Pelotonia Idea Grant, this initial pilot study will be used to collect preliminary data on feasibility and safety of the procedure to support larger-scale studies in the future.
Primary research measures include:
- feasibility of removal of breast gland en bloc through RNSM
- complication rate of patients with bleeding requiring re-operation or infection requiring antibiotics or re-operation
- complication rate of patients with mastectomy flap (SKIN flap score)
- perioperative outcomes investigating the total duration of surgical time, length of surgery time and length of hospitalization
Secondary outcome measures include:
- surgeon musculoskeletal fatigue with RNSM using a Surgery Task Load Index (SURG-TLX) survey and musculoskeletal (NMSQ) questionnaire
- patient-reported outcomes for sensation recovery and satisfaction measured by a BREAST-Q survey
Video summary
As principal investigator, Dr. Park provides an overview of her study in this video.
Patient recruitment
Recruitment is ongoing. For more information or to refer a patient, please contact The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at 800-293-5066 or OSUCCCClinicaltrials@osumc.edu. Please reference the study’s ClinicalTrials.gov identifier (NCT number) as NCT04537312.