RCT Implant Based Breast Reconstruction (NCT04558138) | Clinical Trial Compass
CompletedNot Applicable
RCT Implant Based Breast Reconstruction
United States123 participantsStarted 2020-08-20
Plain-language 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.
Who can participate
Age range19 Years – 80 Years
SexFEMALE
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Inclusion criteria
✓. 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 undergoing sub-pectoral and pre-pectoral breast implant reconstructive techniques will be both included.
✓. All adult (\>18 years old), female patients who will undergo mastectomy for breast cancer or prophylaxis and immediate implant-based reconstruction who are able to complete surveys independently will be eligible for the study.
✓. English and Spanish speaking
✓. Patients will be included regardless of their current chemoradiation plan
Exclusion criteria
✕. Age \> 80 years
✕. ASA 4
✕. suboxone use
✕. documented substance use disorder as defined by the DSM-5 (I.e. alcohol use disorder, opioid use disodrer, cocaine use disorder, etc). Marijuana use will not be considered a substance use disorder
✕. OSA requiring CPAP
✕. recent pneumonia (within 6 weeks)
✕. BMI \> 45 kg/m2 with any co-morbid condition that is not well controlled
What they're measuring
1
Rate of post-operative complications surgical site infection
Timeframe: Up to 30 Days
2
Number of Participants with Post-operative hematoma
Timeframe: Up to 30 Days
3
Number of Participants with Post-operative blood clots
Timeframe: Up to 30 Days
4
Number of Participants with Post-operative emergency department visits
Timeframe: Up to 30 Days
5
Number of Participants with Post-operative hospital readmissions
Timeframe: Up to 30 Days
6
Number of Participants with Post-operative re-operation