Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anatomic Stage IIA Breast Cancer AJCC v8
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage IA Breast Cancer AJCC v8
- Anatomic Stage IB Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Prophylactic Mastectomy
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage II Breast Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Anatomic Stage IIB Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage IIA Breast Cancer AJCC v8
- Ductal Breast Carcinoma In Situ
- Prognostic Stage I Breast Cancer AJCC v8
- Prognostic Stage IA Breast Cancer AJCC v8
- Prognostic Stage IB Breast Cancer AJCC v8
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
With the advances of breast reconstruction after mastectomy for the treatment of breast diseases including breast cancer, surgical techniques have evolved to preserve the skin flaps and nipple areolar complex (NAC) to give better aesthetic outcome without compromising outcome. Mastectomy that preser...
With the advances of breast reconstruction after mastectomy for the treatment of breast diseases including breast cancer, surgical techniques have evolved to preserve the skin flaps and nipple areolar complex (NAC) to give better aesthetic outcome without compromising outcome. Mastectomy that preserves the NAC is called nipple sparing mastectomy (NSM). NSM can provide major psychosocial benefits for patients but is technically demanding and challenging to perform. Total mammary glandular excision in NSM can be technically challenging due to small size of the incision and poor visualization of dissection plane. Recent studies demonstrate feasibility and safety of performing minimally invasive robot-assisted NSM (RNSM). The technique of RNSM is still novel. This is a single-arm pilot study for feasibility and safety of RNSM.
Tracking Information
- NCT #
- NCT04537312
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ko Un Park, MD Ohio State University Comprehensive Cancer Center
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