CClinicalTrials.gg
Status unknownNCT04596683Updated Oct 22, 2020

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

An interventional study of Same-day NSM or SSM in Breast Cancer, Mastectomy; Lymphedema and Same Day Surgery, sponsored by Georgetown University. Status unknown at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-22.

Sponsored by Georgetown University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Feb 2020, registered May 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

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

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03

In context

Lymphedema

560 studies on the registry are indexed under Lymphedema; 135 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 403 interventional studies indexed under Lymphedema.

Browse Lymphedema studies →

Lead sponsor

Georgetown University is the lead sponsor of 286 studies on the registry; 42 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    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.

    Procedure: Same-day NSM or SSM

Interventions

  • ProcedureSame-day NSM or SSM

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

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What researchers measure

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.

    Time frame: Pre-op to Post-op Day 7

Secondary outcomes

  1. Complications

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

    Time frame: up to 30days post-op

  2. 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.

    Time frame: Preop to Post-op day 1

Other outcomes

  1. 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

    Time frame: Up to post-op day 20

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Study locations

3 of 3 sites recruiting
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References and documents

Publications

  • 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. PubMed 34228679 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04596683
Lead sponsor
Georgetown University
Responsible party
Sponsor
First posted
Oct 22, 2020
Start date
Feb 4, 2020
Primary completion
Feb 4, 2021 (estimated)
Completion
Feb 4, 2022 (estimated)
Last update
Oct 22, 2020

Study contacts

Idanis M Perez-Alvarez, BS
Contact
imp22@georgetown.edu
321-266-7579
Eleni A Tousimis, MD
principal investigator · Medstar Georgetown Attending Physician

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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