NCT04596683

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

Status unknown NA Last updated 22 October 2020

What this trial tests

NA trial testing Same-day NSM or SSM in Breast Cancer in 60 participants. Status unknown.

Timeline

4 February 2020

Primary endpoint
4 February 2021

4 February 2022

Quick facts

Lead sponsor	Georgetown University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	4 February 2020
Primary completion	4 February 2021
Estimated completion	4 February 2022
Sites	3 locations across United States

Drugs / interventions tested

• Same-day NSM or SSM

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Mastectomy; Lymphedema — all drugs for Mastectomy; Lymphedema →
• Same Day Surgery — all drugs for Same Day Surgery →
• Nipple-sparing Mastectomy — all drugs for Nipple-sparing Mastectomy →

Sponsor

Georgetown University

Who can join

18 and older, female only, with Breast Cancer or Mastectomy; Lymphedema. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Perez-Alvarez IM, Tousimis EA. · · 2021 · PMID 34228679 · DOI 10.1097/prs.0000000000008159