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

Primary Purpose

Breast Cancer, Mastectomy; Lymphedema, Same Day Surgery

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Same-day NSM or SSM
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Medstar Georgetown UniversityRecruiting
  • Medstar Washington Hospital CenterRecruiting
  • Medstar Franklin Square Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interested in SDS NSM or SSM

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Complications
frequencies of infection, hematomas, return to emergency room or urgent care
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.

Full Information

First Posted
May 13, 2020
Last Updated
October 19, 2020
Sponsor
Georgetown University
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1. Study Identification

Unique Protocol Identification Number
NCT04596683
Brief Title
Same-Day Discharge After Nipple-sparing Mastectomy or Skin-sparing Mastectomy With Breast Reconstruction
Official Title
Same-Day Discharge After Nipple-sparing Mastectomy or Skin-sparing Mastectomy With Breast Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
February 4, 2021 (Anticipated)
Study Completion Date
February 4, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Mastectomy; Lymphedema, Same Day Surgery, Nipple-sparing Mastectomy, Skin-sparing Mastectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interested in SDS NSM or SSM
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Same-day NSM or SSM
Intervention Description
Discharge home same-day after nipple-sparing mastectomy (NSM), or skin-sparing mastectomy (SSM)
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
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.
Time Frame
Pre-op to Post-op Day 7
Secondary Outcome Measure Information:
Title
Complications
Description
frequencies of infection, hematomas, return to emergency room or urgent care
Time Frame
up to 30days post-op
Title
Pain Scores
Description
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.
Time Frame
Preop to Post-op day 1
Other Pre-specified Outcome Measures:
Title
Opioid use
Description
Post-op narcotic use recorded in log brought home by patients.Use to calculate average use per day after discharge and trends postoperatively
Time Frame
Up to post-op day 20

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Idanis M Perez-Alvarez, BS
Phone
321-266-7579
Email
imp22@georgetown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleni A Tousimis, MD
Organizational Affiliation
Medstar Georgetown Attending Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medstar Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Idanis M Perez-Alvarez, BS
Phone
321-266-7479
Email
imp22@georgetown.edu
First Name & Middle Initial & Last Name & Degree
Eleni A Tousimis, MD
Email
eleni.a.tousimis@gunet.georgetown.edu
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Boisvert, MD
Email
marc.e.boisvert@medstar.net
Facility Name
Medstar Franklin Square Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Fernandez, MD
Email
kristen.fernandez@medstar.net

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34228679
Citation
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.
Results Reference
derived

Learn more about this trial

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

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