Study Summary
This trial will compare outcomes of patients discharged the day of surgery versus the day after for those undergoing mastectomy with immediate implant-based breast reconstruction.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 6 Secondary · Reporting Duration: Up to 30 Days
Post-Operative day 7
Discharge perceptions
Opioid Consumption
Up to 30 Days
Number of Participants with Post-operative blood clots
Number of Participants with Post-operative emergency department visits
Number of Participants with Post-operative hematoma
Number of Participants with Post-operative hospital readmissions
Number of Participants with Post-operative re-operation
Opioid adverse effects
Pain Score
Quality of life perceptions: PROMIS-29
Quality of life perceptions: QoR-15
Rate of post-operative complications surgical site infection
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Discharge post operative day 1
1 of 2
Discharge day of surgery
1 of 2
Active Control
Experimental Treatment
100 Total Participants · 2 Treatment Groups
Primary Treatment: Discharge timing · No Placebo Group · N/A
Discharge day of surgery
Other
Experimental Group · 1 Intervention: Discharge timing · Intervention Types: OtherDischarge post operative day 1NoIntervention Group · 1 Intervention: Discharge post operative day 1 · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 days
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,098 Previous Clinical Trials
41,145,677 Total Patients Enrolled
1 Trials studying Mastectomy
30 Patients Enrolled for Mastectomy
University of Colorado, DenverLead Sponsor
1,596 Previous Clinical Trials
1,929,030 Total Patients Enrolled
Christodoulos Kaotzanis, MDPrincipal InvestigatorUniversity of Colorado, Denver
Eligibility Criteria
Age 19 - 80 · Female Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Patients undergoing sub-pectoral and pre-pectoral breast implant reconstructive techniques will be both included.
Patients who will undergo immediate, (unilateral or bilateral)implant-based breast reconstruction following mastectomy for breast cancer or prophylaxis at the University of Colorado Anschutz Medical Campus and Highlands Ranch Campus.
Patients will be included regardless of their current chemoradiation plan.
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Conditions
Cancer Related
Treatments