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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
123
Patients will be discharged home on the day of surgery as opposed to POD #1
University of Colorado Hospital
Aurora, Colorado, United States
Rate of post-operative complications surgical site infection
Assessed by patient report
Time frame: Up to 30 Days
Number of Participants with Post-operative hematoma
Assessed by patient report
Time frame: Up to 30 Days
Number of Participants with Post-operative blood clots
Assessed by patient report
Time frame: Up to 30 Days
Number of Participants with Post-operative emergency department visits
Assessed by patient report
Time frame: Up to 30 Days
Number of Participants with Post-operative hospital readmissions
Assessed by patient report
Time frame: Up to 30 Days
Number of Participants with Post-operative re-operation
Assessed by patient report
Time frame: Up to 30 Days
Pain Score
Pain control, as measured by a visual analog Numeric Pain Scale (NPS) number ranging from 0 (no pain at all) to 10 (worst pain ever) between the two groups.
Time frame: Up to 30 Days
Opioid Consumption
The following information will be collected from a combination of patient reported information and electronic medical review: amount of supplemental postoperative opioid analgesia (both intravenous and oral) used by the study participant from postoperative days 0 to 7.
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Time frame: Post-Operative day 7
Opioid adverse effects
The following effects/symptoms will be recorded as YES or NO if required admission to the hospital for management including use of IV medications: nausea, vomiting, constipation and urinary retention.
Time frame: Up to 30 Days
Quality of life perceptions: QoR-15
QoR-15: This scale will be utilized to evaluate patient satisfaction. It captures patient reported postoperative assessment of various dimensions of health including patient support, comfort, emotions, physical independence, and pain. Patients rate each of the 15 statements from 1 (never) to 10 (always).
Time frame: Up to 30 Days
Discharge perceptions
Group A: Discharged the same day of surgery will be asked the following questions on postoperative 7: Did you feel that you were discharge home at the appropriate time? How uncomfortable were you the night of surgery, as measured by a visual analog NPS number ranging from 0 (not uncomfortable) to 10 (extremely uncomfortable)? What was the main benefit of going home right after surgery? What was your biggest complaint about being at home right after surgery? Group B: Patients admitted after surgery will be asked the following questions on postoperative 7: Did you feel that you were discharge home at the appropriate time? How uncomfortable were you the night of surgery, as measured by a visual analog NPS number ranging from 0 (not uncomfortable) to 10 (extremely uncomfortable)? What was the main benefit of being admitted to the hospital after surgery? What was your biggest complaint about being at the hospital after surgery?
Time frame: Post-Operative day 7
Quality of life perceptions: PROMIS-29
PROMIS-29: A generic health-related quality of life survey, assesses each of the 7 PROMIS domains with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity part of the PROMIS-29 (with 0 being "no pain" and 10 being "worst imaginable pain")
Time frame: Up to 30 Days