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

Washington, United States
N/A
Waitlist Available
Led By Eleni A Tousimis, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30days post-op
Awards & highlights
No Placebo-Only Group

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.

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Eligible Conditions
  • Breast Cancer
  • Breast cancer
  • Same Day Surgery
  • Nipple Sparing Mastectomy
  • Skin-sparing Mastectomy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30days post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30days post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient satisfaction
Secondary study objectives
Complications
Pain Scores
Other study objectives
Opioid use

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Interested in SDS NSM or SSMExperimental Treatment1 Intervention
Patients interested same day discharge after NSM or SSM that do not have conditions that would exclude them. Based on discharge outcome after surgery, will be split into SDS group and Admit group.

Find a Location

Closest Location:Medstar Georgetown University· Washington, United States· 325 miles

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
354 Previous Clinical Trials
142,131 Total Patients Enrolled
Eleni A Tousimis, MDPrincipal InvestigatorMedstar Georgetown Attending Physician
~10 spots leftby Mar 2026