Clinical trial NCT04596683: Same-Day Discharge After Nipple-sparing Mastectomy or Skin-sparing Mastectomy With Breast Reconstruction
Official title: Same-Day Discharge After Nipple-sparing Mastectomy or Skin-sparing Mastectomy With Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Mastectomy; Lymphedema
Same Day Surgery
Nipple-sparing Mastectomy
Skin-sparing Mastectomy
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Patient satisfaction
timeFrame: Pre-op to Post-op Day 7
Secondary outcomes:
measure: Complications
timeFrame: up to 30days post-op
measure: Pain Scores
timeFrame: Preop to Post-op day 1
Other outcomes:
measure: Opioid use
timeFrame: Up to post-op day 20
Locations:
city: Washington
country: United States
facility: Medstar Georgetown University
state: District of Columbia
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Baltimore
country: United States
facility: Medstar Franklin Square Medical Center
state: Maryland
Study officials:
affiliation: Medstar Georgetown Attending Physician
name: Eleni A Tousimis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.