NCT04558138

RCT Implant Based Breast Reconstruction

A Randomized Controlled Trial in Patients Undergoing Immediate Implant-Based Breast Reconstruction Utilizing an Enhanced Recovery Pathway Comparing Outcomes and Patient Satisfaction Based on Time of Discharge

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Traditionally patients undergoing mastectomy with immediate implant-based breast reconstruction were admitted to the hospital overnight. However, recent retrospective studies utilizing ERAS protocols have reported same day discharge as a possibility for this patient population. ERAS protocols for breast cancer surgery and reconstruction are becoming more popular. This along with the increasing utilization of prepectoral breast reconstruction that is associated with less postoperative pain and opioid use, are promising avenues to decrease the need for overnight hospital stay. If it can be shown that discharge on the same day of surgery does not pose any major risks compared to discharge on post-operative day one, there is the potential to decrease length of hospital stay, improve hospital capacity and dramatically decrease costs.

Conditions

• Mastectomy

Interventions

Type	Name	Description
OTHER	Discharge timing	Patients will be discharged home on the day of surgery as opposed to POD #1

Timeline

• Start date: 2020-08-20
• Primary completion: 2024-01-16
• Completion: 2025-10-13
• First posted: 2020-09-22
• Last updated: 2025-11-05

Locations

1 site across 1 country: United States