Breast Cancer Clinical Trial

Same-Day Discharge After Nipple-sparing Mastectomy or Skin-sparing Mastectomy With Breast Reconstruction

Summary

This novel study will assess the feasibility and outcomes of same-day discharge following mastectomy with implant-based pre-pectoral reconstruction. This contrasts the current standard practice of admitting patients to the hospital as an inpatient for at least one night postoperatively. With the advent of pre-pectoral implant-based reconstructive techniques as opposed to the historical retro-pectoral breast reconstruction, patients experience significantly less post-operative pain, shorter recovery time, and improved mobility all of which support that patients lacking comorbidities are likely to meet discharge criteria the same day as surgery. Furthermore, advances in opioid sparing anesthesia and the Enhanced Recovery After Anesthesia protocol, has dramatically reduced pain scores and narcotic requirements after surgery at our institution. "Same day discharge" may reduce healthcare costs, decreases the risk of hospital-acquired infections and can increase patient satisfaction. Potential risks associated with same day discharge include readmissions, infections, limitations to pain management and other complications. The study will be conducted at MedStar System Hospitals and the population will be patients receiving pre-pectoral breast reconstruction following mastectomy that consent to the study. The project will be conducted as a prospective study where a carefully selected group of women without comorbidities undergoing mastectomy and pre-pectoral implant-based reconstruction will be offered same day discharge, educated about postoperative care preoperatively, be evaluated in the PACU and if they meet discharge criteria, will go home the same day as surgery. Those women who do not meet discharge criteria will stay overnight and be followed for outcomes, as well, as a comparison group. The primary endpoint for this study is patient satisfaction. Secondary outcomes include pain, complications including infection, hematomas, return to emergency room or urgent care, opiate equivalent use, and whether a patient would recommend same day discharge to others. Statistical analysis using means, 95% CI, frequency counts, descriptive statistics, fisher exact test and independent t-tests will evaluate differences between the same day discharge and admitted groups. Please see section 6 in the IRB protocol for more detail. We hypothesize that same day discharge provides acceptable patient satisfaction, pain control, complication rates with similar opiate equivalent use in comparison with overnight admission. Overall, we think this group will demonstrate positive outcomes on its own in these categories. We also believe that this study will demonstrate patients with same day discharge will recommend it to other women undergoing mastectomy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients either receiving nipple-sparing mastectomy or skin sparing mastectomy
Patients with new diagnosis of cancer receiving mastectomy or those receiving mastectomy for preventative surgery
Receiving implant-based pre-pectoral breast reconstruction
Patients whose treatment is to be completed at MedStar System Hospitals
Amenable to option of SDS prior to surgery
Capable of giving informed consent

Exclusion Criteria:

Active Smoker
Patients with high risk comorbidities (significant cardiac disease, diabetes) that necessitate prolonged postoperative in house course

Study is for people with:

Breast Cancer

Estimated Enrollment:

60

Study ID:

NCT04596683

Recruitment Status:

Unknown status

Sponsor:

Georgetown University

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There are 3 Locations for this study

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Medstar Georgetown University
Washington District of Columbia, 20007, United States More Info
Idanis M Perez-Alvarez, BS
Contact
321-266-7479
[email protected]
Eleni A Tousimis, MD
Contact
[email protected]
Medstar Washington Hospital Center
Washington District of Columbia, 20010, United States More Info
Marc Boisvert, MD
Contact
[email protected]
Medstar Franklin Square Medical Center
Baltimore Maryland, 21237, United States More Info
Kristen Fernandez, MD
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

60

Study ID:

NCT04596683

Recruitment Status:

Unknown status

Sponsor:


Georgetown University

How clear is this clinincal trial information?

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