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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
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.
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.
Age
19 - 80 years
Sex
FEMALE
Healthy Volunteers
No
University of Colorado Hospital
Aurora, Colorado, United States
Start Date
August 20, 2020
Primary Completion Date
January 16, 2024
Completion Date
October 13, 2025
Last Updated
November 5, 2025
123
ACTUAL participants
Discharge timing
OTHER
Lead Sponsor
University of Colorado, Denver
Collaborators
NCT07147166
NCT04891510
Data Source & Attribution
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