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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04596683
• Other study ID #: 00000441
• Status: Recruiting
• Phase: N/A
• Start date: February 4, 2020
• Est. completion date: February 4, 2022

Study information

• Verified date: October 2020
• Source: Georgetown University
• Contact: Idanis M Perez-Alvarez, BS
• Phone: 321-266-7579
• Email: imp22[@]georgetown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 4, 2022
• Est. primary completion date: February 4, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Lymphedema
• Mastectomy; Lymphedema
• Nipple-sparing Mastectomy
• Same Day Surgery
• Skin-sparing Mastectomy

Intervention

Procedure:
• Same-day NSM or SSM
Discharge home same-day after nipple-sparing mastectomy (NSM), or skin-sparing mastectomy (SSM)

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Complications	frequencies of infection, hematomas, return to emergency room or urgent care	up to 30days post-op
Secondary	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