Recruiting

Same-Day Discharge

Sponsor:

Georgetown University

Code:

NCT04596683

Conditions

Breast Cancer

Mastectomy; Lymphedema

Same Day Surgery

Nipple-sparing Mastectomy

Skin-sparing Mastectomy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Same-day NSM or SSM

Study Details

Brief 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.

Conditions

Breast Cancer

Mastectomy; Lymphedema

Same Day Surgery

Nipple-sparing Mastectomy

Skin-sparing Mastectomy

Study ID

NCT04596683

Start date

Feb 4, 2020

Status verified date

Oct, 2020

Completion date

Feb 4, 2022

Anticipated

Primary completion date

Feb 4, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Interested in SDS NSM or SSM

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.

Interventions

Same-day NSM or SSM

Discharge home same-day after nipple-sparing mastectomy (NSM), or skin-sparing mastectomy (SSM)

Primary outcome measure

  • Patient satisfaction [ Time Frame: Pre-op to Post-op Day 7 ]

Central Contacts and Locations

Central contacts

Idanis M Perez-Alvarez, BS

321-266-7579imp22@georgetown.edu

Locations

Medstar Georgetown University

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

Medstar Washington Hospital Center

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

Medstar Franklin Square Medical Center

Recruiting

Baltimore, Maryland, United States, 21237

Contacts

Kristen Fernandez, MD

kristen.fernandez@medstar.net

More Information

Sponsor

Georgetown University

Last update posted

Oct 22, 2020

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2020-10-22.