Clinical trial NCT04558138: RCT Implant Based Breast Reconstruction
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mastectomy
Keywords: Reconstruction
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-09-22
Enrollment: 123
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After consent, patients will be randomized into one of two groups, either discharged day of surgery, or discharged day after surgery
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patients undergoing sub-pectoral and pre-pectoral breast implant reconstructive techniques will be both included.
3. 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.
4. English and Spanish speaking
5. Patients will be included regardless of their current chemoradiation plan

Exclusion Criteria:

1. Age \> 80 years
2. ASA 4
3. suboxone use
4. 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
5. OSA requiring CPAP
6. recent pneumonia (within 6 weeks)
7. BMI \> 45 kg/m2 with any co-morbid condition that is not well controlled
8. poorly controlled diabetes (HgbA1c \> 9)
9. Not English or Spanish speaking

Primary outcomes:
measure: Rate of post-operative complications surgical site infection
timeFrame: Up to 30 Days
measure: Number of Participants with Post-operative hematoma
timeFrame: Up to 30 Days
measure: Number of Participants with Post-operative blood clots
timeFrame: Up to 30 Days
measure: Number of Participants with Post-operative emergency department visits
timeFrame: Up to 30 Days
measure: Number of Participants with Post-operative hospital readmissions
timeFrame: Up to 30 Days
measure: Number of Participants with Post-operative re-operation
timeFrame: Up to 30 Days
Secondary outcomes:
measure: Pain Score
timeFrame: Up to 30 Days
measure: Opioid Consumption
timeFrame: Post-Operative day 7
measure: Opioid adverse effects
timeFrame: Up to 30 Days
measure: Quality of life perceptions: QoR-15
timeFrame: Up to 30 Days
measure: Discharge perceptions
timeFrame: Post-Operative day 7
measure: Quality of life perceptions: PROMIS-29
timeFrame: Up to 30 Days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Christodoulos Kaotzanis, MD
role: PRINCIPAL_INVESTIGATOR
References: