Breast Cancer, Mastectomy; Lymphedema, Nipple-sparing Mastectomy, Same Day Surgery, Skin-sparing Mastectomy
Conditions
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.
Interventions
PROCEDURESame-day NSM or SSM
Discharge home same-day after nipple-sparing mastectomy (NSM), or skin-sparing mastectomy (SSM)
Sponsors
Georgetown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | Pre-op to Post-op Day 7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | up to 30days post-op | frequencies of infection, hematomas, return to emergency room or urgent care |
| Pain Scores | Preop to Post-op day 1 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Opioid use | Up to post-op day 20 | Post-op narcotic use recorded in log brought home by patients.Use to calculate average use per day after discharge and trends postoperatively |
Countries
United States
Contacts
Primary ContactIdanis M Perez-Alvarez, BS
Outcome results
None listed