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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal discharge timing for patients undergoing mastectomy with immediate implant-based breast reconstruction. It compares outcomes for patients discharged on the day of surgery versus those discharged the next day, focusing on recovery, complications, and overall satisfaction within the first 30 days. Women with breast cancer or those undergoing mastectomy for prevention, who are receiving implant-based reconstruction at specific medical campuses, may be suitable candidates. Participants must be able to complete surveys independently and speak either English or Spanish. As an unphased trial, this study allows participants to contribute to significant research that could enhance post-surgery care for future patients.

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 prior data suggests that this discharge timing is safe for patients undergoing implant-based breast reconstruction?

Research has shown that going home the same day after breast implant surgery is usually safe. Studies have found that most patients who leave the hospital immediately after surgery do not experience more short-term problems than those who stay overnight. This indicates that same-day discharge does not lead to additional issues.

The evidence comes from several studies on patients who underwent this surgery. These studies found that most patients did well and did not encounter more problems by going home early. This suggests that, for most patients, leaving the hospital the same day can be a safe choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the early discharge protocol for implant-based breast reconstruction because it may offer a more convenient and comfortable recovery for patients. Unlike traditional methods where patients remain in the hospital for observation, this approach allows for discharge on the day of surgery, with follow-up assessments conducted at home. This could potentially reduce healthcare costs and free up hospital resources while maintaining patient safety and satisfaction. By enabling patients to recover in their own homes, this method might enhance overall well-being and speed up the recovery process.

What evidence suggests that early discharge is effective for implant-based breast reconstruction?

Research has shown that going home the same day after breast implant surgery is usually safe for most patients. In this trial, one group of participants will be discharged on the day of surgery, while another group will leave on the first postoperative day. A six-year review found that same-day discharge can reduce the likelihood of readmission. Most studies indicate that immediate discharge does not increase short-term problems for carefully selected patients. Notably, over 96% of patients at a particular care facility went home the same day without issues. Overall, these studies suggest that early discharge could be a safe option without raising the risk of complications. ^{2 3 4 5 6}

Who Is on the Research Team?

Christodoulos Kaotzanis, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11177554/

Same Day Discharge After Mastectomy and Immediate ... A retrospective review of the NSQIP database over a 6-year period revealed that same-day discharge is associated with lower rates of readmission, with no ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9298472/

The Safety of Same-day Discharge after Immediate ... Meaning: Most evidence shows that in a majority of patients, same-day discharge after immediate, alloplastic breast reconstruction is safe.

3. jprasurg.com jprasurg.com/article/S1748-6815(25)00535-2/pdf

Journal Pre-proof Same-day discharge after DTI breast reconstruction was safe, with no increase in short-term complications, among appropriately selected patients ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681520300383

Successful same day discharge after immediate post- ... Greater than 96% of patients receiving care at the day care facility were successfully discharged. The success rate for same day discharge at the RH was 65%. We ...

5. withpower.com withpower.com/trial/phase-7-2020-62daf

Early Discharge for Implant-Based Breast Reconstruction 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 ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681525005352

National Trends and Outcomes of Same-Day Discharge ... Same-day discharge after DTI breast reconstruction was safe, with no increase in short-term complications, among appropriately selected patients ...