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

NCT ID: NCT04596683

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-04
• Study Completion Date: 2022-02-04

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interested in SDS 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.

Group Type: EXPERIMENTAL

Same-day NSM or SSM

Intervention Type: PROCEDURE

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

Interventions

Same-day NSM or SSM

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eleni A Tousimis, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Georgetown Attending Physician

Locations

Medstar Georgetown University

Washington D.C., District of Columbia, United States

Site Status: RECRUITING

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status: RECRUITING

Medstar Franklin Square Medical Center

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Idanis M Perez-Alvarez, BS

Role: CONTACT

imp22@georgetown.edu

321-266-7579

Facility Contacts

Idanis M Perez-Alvarez, BS

Role: primary

imp22@georgetown.edu

321-266-7479

Eleni A Tousimis, MD

Role: backup

eleni.a.tousimis@gunet.georgetown.edu

Marc Boisvert, MD

Role: primary

marc.e.boisvert@medstar.net

Kristen Fernandez, MD

Role: primary

kristen.fernandez@medstar.net

References

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.

Reference Type: DERIVED

PMID: 34228679 (View on PubMed)

Other Identifiers

00000441

Identifier Type: -

Identifier Source: org_study_id