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

NCT04596683 | Unknown

• 1 other identifier: 00000441
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Complications

  up to 30days post-op

• Pain Scores

  Preop to Post-op day 1

Other Outcomes (1)

• Opioid use

  Up to post-op day 20

Study Arms (1)

Interested in SDS NSM or SSM

EXPERIMENTAL

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.

Procedure: Same-day NSM or SSM

Interventions

Same-day NSM or SSM PROCEDURE

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

Interested in SDS NSM or SSM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active Smoker
• Patients with high risk comorbidities (significant cardiac disease, diabetes) that necessitate prolonged postoperative in house course

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (3)

Medstar Georgetown University

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Medstar Franklin Square Medical Center

Baltimore, Maryland, 21237, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 34228679 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Interventions

specific substance maruyama

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Eleni A Tousimis, MD

  Medstar Georgetown Attending Physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Idanis M Perez-Alvarez, BS

CONTACT

321-266-7579; imp22@georgetown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: October 22, 2020
• Study Start: February 4, 2020
• Primary Completion: February 4, 2021
• Study Completion: February 4, 2022
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)