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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Mastectomy; Lymphedema; Nipple-sparing Mastectomy; Same Day Surgery; Skin-sparing Mastectomy
• Intervention / Treatment: Procedure: Same-day NSM or SSM

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Idanis M Perez-Alvarez, BS; Phone Number: 321-266-7579; Email: imp22@georgetown.edu

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • MedStar Washington Hospital Center
      • Contact: Marc Boisvert, MD; Email: Marc.E.Boisvert@medstar.net
    • Washington, District of Columbia, United States, 20007
      • Recruiting
      • Medstar Georgetown University
      • Contact: Idanis M Perez-Alvarez, BS; Phone Number: 321-266-7479; Email: imp22@georgetown.edu
      • Contact: Eleni A Tousimis, MD; Email: eleni.a.tousimis@gunet.georgetown.edu
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Recruiting
      • MedStar Franklin Square Medical Center
      • Contact: Kristen Fernandez, MD; Email: kristen.fernandez@medstar.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Same-day NSM or SSM; Discharge home same-day after nipple-sparing mastectomy (NSM), or skin-sparing mastectomy (SSM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Breast Q Survey Scores pre and post-op. All scores calculated on scale of 100 further divided into sections scored out of 100 analyzing psychosocial, physical, appearance, and care outcomes. Higher scores associated with better satisfaction.	Pre-op to Post-op Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	frequencies of infection, hematomas, return to emergency room or urgent care	up to 30days post-op
Pain Scores	American Pain Society Post-operative Outcome Survey pre and post-op surveys. Scored on basis of answers of 12 questions, divided into 5 categories of questions. Most composite category scores are associated with higher scores equaling poorer outcomes except for "perceptions of care" where higher scores demonstrate improved outcomes.	Preop to Post-op day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid use	Post-op narcotic use recorded in log brought home by patients.Use to calculate average use per day after discharge and trends postoperatively	Up to post-op day 20

Collaborators and Investigators

• Sponsor: Georgetown University
• Investigators: Principal Investigator: Eleni A Tousimis, MD, Medstar Georgetown Attending Physician

Publications and helpful links

General Publications

• Perez-Alvarez IM, Tousimis EA. Reply: Breast Surgery in the Time of Global Pandemic: Benefits of Same-Day Surgery for Breast Cancer Patients Undergoing Mastectomy with Immediate Reconstruction during COVID-19. Plast Reconstr Surg. 2021 Aug 1;148(2):325e-326e. doi: 10.1097/PRS.0000000000008159. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2020
• Primary Completion (Anticipated): February 4, 2021
• Study Completion (Anticipated): February 4, 2022

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 00000441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No