Early Discharge for Implant-Based Breast Reconstruction

Overseen By Christodoulos Kaoutzanis

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Suboxone

Disqualifiers: Age > 80, ASA 4, substance use disorder, OSA with CPAP, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

123 Participants Needed

Trial Summary

What is the purpose of this trial?

The main objective of this study is to evaluate patients undergoing mastectomy with immediate implant-based breast reconstruction and compare the outcomes of patients who are discharged the day of surgery versus patients who are discharged on post-operative day one. The primary aim of the study will be to compare the postoperative outcomes and complications between the two study groups within 30 days of discharge. The secondary aims of the study will be to compare patient satisfaction, quality of life and discharge perceptions.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Discharge timing, Implant Based Breast Reconstruction?

The study on same-day discharge after implant-based breast reconstruction suggests that it is safe and feasible compared to the standard overnight stay, indicating that early discharge might be an effective option for patients. ^{1 2 3 4 5}

Is early discharge after implant-based breast reconstruction safe?

Research shows that implant-based breast reconstruction is common but can have complications, such as infections. However, studies suggest that same-day discharge after this procedure can be safe and feasible, similar to the standard overnight stay. ^{1 5 6 7 8}

How is the treatment for early discharge in implant-based breast reconstruction different from other treatments?

This treatment is unique because it allows patients to be discharged on the same day as their implant-based breast reconstruction surgery, rather than staying overnight in the hospital, which is the current standard practice. This approach is being studied for its safety and effectiveness compared to the traditional overnight stay. ^{1 6 9 10 11}

Research Team

Christodoulos Kaotzanis, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for adult women over 18 who are having immediate implant-based breast reconstruction after a mastectomy at the University of Colorado's medical campuses. It includes those with any chemoradiation plan and speaks English or Spanish. Excluded are individuals with severe obesity, high surgical risk (ASA 4), certain substance use disorders, extreme age (>80), uncontrolled diabetes, sleep apnea needing CPAP, or recent pneumonia.

Inclusion Criteria

I can speak English and Spanish.

My treatment plan includes chemoradiation.

I am having immediate implant-based breast reconstruction after mastectomy at the specified locations.

Exclusion Criteria

I have a severe systemic disease that is a constant threat to my life.

I have not had pneumonia in the last 6 weeks.

You have obstructive sleep apnea and require a continuous positive airway pressure (CPAP) machine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Post-operative Care

Participants undergo mastectomy with immediate implant-based breast reconstruction and are discharged either the same day or on post-operative day one

1-2 days

1 visit (in-person)

Follow-up

Participants are monitored for post-operative outcomes and complications, including patient satisfaction and quality of life assessments

Up to 30 days

Surveys on post-operative days 1 and 7

Treatment Details

Interventions

• Discharge timing
• Implant Based Breast Reconstruction

Trial Overview The study compares outcomes of patients discharged on the same day as their mastectomy and implant-based breast reconstruction versus those discharged the next day. It focuses on postoperative complications within 30 days and also looks at patient satisfaction, quality of life, and discharge perceptions.

Participant Groups

Group I: Discharge day of surgery Experimental Treatment 1 Intervention

Patient discharges day of surgery and given surveys to complete at home on post operative day (POD) #1 and #7.

Group II: Discharge post operative day 1 Active Control 1 Intervention

Patient Discharges POD #1 and completes survey prior to discharge. Patient given surveys to complete POD #7 at home.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 84,296 women undergoing breast augmentation, the rate of major adverse events was found to be low at 0.37%, with specific complications like seroma and hematoma occurring in 0.08% and 0.15% of cases, respectively.

Key risk factors for these adverse events included a body mass index over 30 kg/m2, tobacco use, and diabetes, with the use of a periareolar incision significantly increasing the risk of complications compared to an inframammary incision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incision Location Predicts 30-Day Major Adverse Events after Cosmetic Breast Augmentation: An Analysis of the Tracking Outcomes and Operations for Plastic Surgeons Database. Valente, DS., Pannucci, CJ., King, TW., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Same Day Discharge After Mastectomy and Immediate Implant-Based Breast Reconstruction: A Retrospective Cohort Comparison Using the National Surgical Quality Improvement Program Database. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

How Postoperative Infection Affects Reoperations after Implant-based Breast Reconstruction: A National Claims Analysis of Abandonment of Reconstruction. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Late Surgical-Site Infection in Immediate Implant-Based Breast Reconstruction. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Modern Approaches to Implant-Based Breast Reconstruction. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The Timing of Acute and Late Complications Following Mastectomy and Implant-based Reconstruction. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A single-centre, retrospective proof-of-concept review of salvage of infected or exposed implant breast reconstructions with explantation and one-stage free flap replacement. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Incision Location Predicts 30-Day Major Adverse Events after Cosmetic Breast Augmentation: An Analysis of the Tracking Outcomes and Operations for Plastic Surgeons Database. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Comparison of surgical complication between immediate implant and autologous breast reconstruction after mastectomy: A multicenter study of 426 cases. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Same-day Discharge Is Safe and Effective After Implant-Based Breast Reconstruction. [2023]

10. Italy pubmed.ncbi.nlm.nih.gov

Insights on DRGs, guideline compliance and economic sustainability. The case of mastectomy with immediate breast reconstruction. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Skin-reducing mastectomy and one-stage implant reconstruction with a myodermal flap: a safe and effective technique in risk-reducing and therapeutic mastectomy. [2022]