This trial compares the outcomes of patients who are discharged the day of surgery versus patients who are admitted to the hospital and get discharged the following day who underwent immediate implant-based breast reconstruction after surgery. An enhanced recovery pathway program may help to decrease the hospital length of stay, decrease postoperative opioid use, and improve patients’ overall experience.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04558138.
PRIMARY OBJECTIVE:
I. Compare the postoperative outcomes and complications (for the first 30 days) between the two study groups (including emergency room visits, hospital readmissions, and reoperations).
SECONDARY OBJECTIVE:
I. Compare post-operative patient satisfaction and quality of life, post-operative opioid information (including outcomes such as pain control, amount of opioids use, opioid adverse effects like constipation and vomiting) and discharge perceptions (including advantages and disadvantages of discharging from hospital on the day of surgery when compared to post-operative day 1).
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo surgery and are then discharged on the same day. Patients also complete surveys on post-operative days 1 and 7.
GROUP II: Patients undergo surgery and are then discharged on the day after surgery. Patients also complete surveys on post-operative days 1 and 7.
After completion of study, patients are followed for up to 30 days.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUCHealth University of Colorado Hospital
Principal InvestigatorChristodoulos Kaoutzanis