Open Nipple Sparing Mastectomy (NSM)

N/AActive Not RecruitingNCT04447339

Intuitive Surgical75 enrolled

Overview

This is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively

Study Type

OBSERVATIONAL

Enrollment

Conditions

Nipple Sparing Mastectomy

Interventions

Nipple Sparing MastectomyPROCEDURE

Prophylactic open NSM procedures

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: All female patients that have undergone open prophylactic NSM cases performed between January 1, 2018 through 42 days prior to IRB approval Exclusion Criteria: \-

Locations (5)

NorthShore University Health System

Evanston, Illinois, United States

Mayo Clinic Hosp - Methodist Campus - MN

Rochester, Minnesota, United States

Northwell Health

Queens, New York, United States

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Safety Endpoint: complication rate

To assess the number of open prophylactic nipple sparing mastectomy complications compared to the number of procedures

Time frame: IntraOperative period through 42 days postoperatively

Effectiveness

Ability to completely excise memory gland tissue and preserve Nipple Areola Complex

Time frame: IntraOperative period through 42 days postoperatively

Data from ClinicalTrials.gov

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