Evaluating complication rates after nipple sparing mastectomy
A Retrospective, Multicenter Study of Open Nipple Sparing Mastectomy (NSM)
This study looks at the complication rates after nipple-sparing mastectomy to see how safe and effective the surgery is for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Intuitive Surgical Industry-sponsored |
| Locations | 5 sites (Evanston, Illinois and 4 other locations) |
| Trial ID | NCT04447339 on ClinicalTrials.gov |
What this trial studies
This observational study involves a retrospective, multicenter chart review aimed at assessing the complication rates associated with prophylactic open nipple sparing mastectomy (NSM) procedures. The evaluation will focus on patient outcomes through 42 days postoperatively, utilizing data from multiple healthcare institutions. By analyzing patient records, the study seeks to provide insights into the safety and effectiveness of this surgical approach.
Who should consider this trial
Good fit: Ideal candidates for this study are female patients who have undergone open prophylactic nipple sparing mastectomy between January 1, 2018, and 42 days prior to IRB approval.
Not a fit: Patients who have not undergone nipple sparing mastectomy or those who had surgeries outside the specified timeframe may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the safety profile of nipple sparing mastectomy, potentially leading to improved surgical practices.
How similar studies have performed: While this study is observational and retrospective, similar studies evaluating surgical outcomes have shown promise in improving patient care and safety.
Eligibility criteria
Show full inclusion / exclusion criteria
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: -
Where this trial is running
Evanston, Illinois and 4 other locations
- NorthShore University Health System — Evanston, Illinois, United States (Recruiting)
- Mayo Clinic Hosp - Methodist Campus - MN — Rochester, Minnesota, United States (Recruiting)
- Northwell Health — Queens, New York, United States (Recruiting)
- Pennsylvania Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
- Univ. of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Tish Mikoczi
- Email: tish.mikoczi@intusurg.com
- Phone: 760-274-5811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.