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

Not Applicable

• Conditions: Mastectomy; Lymphedema; Breast Cancer; Same Day Surgery; Skin-sparing Mastectomy; Nipple-sparing Mastectomy
• Interventions: Procedure: Same-day NSM or SSM

• Registration Number: NCT04596683
• Lead Sponsor: Georgetown University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-04
• Study First Submitted: 2020-05-13
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-19
• Last Update Submitted: 2020-10-19
• Study First Posted: 2020-10-22
• Last Update Posted: 2020-10-22
• Primary Completion: 2021-02-04
• Study Completion: 2022-02-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interested in SDS NSM or SSM	Same-day 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Complications	up to 30days post-op	frequencies of infection, hematomas, return to emergency room or urgent care

Trial Locations

Locations (3)

Medstar Franklin Square Medical Center; 🇺🇸 Baltimore, Maryland, United States

Medstar Georgetown University; 🇺🇸 Washington, District of Columbia, United States

Medstar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States