RCT Implant Based Breast Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-20

Study Completion Date

2025-10-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mastectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

After consent, patients will be randomized into one of two groups, either discharged day of surgery, or discharged day after surgery

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Discharge day of surgery

Patient discharges day of surgery and given surveys to complete at home on post operative day (POD) #1 and #7.

Group Type EXPERIMENTAL

Discharge timing

Intervention Type OTHER

Patients will be discharged home on the day of surgery as opposed to POD #1

Discharge post operative day 1

Patient Discharges POD #1 and completes survey prior to discharge. Patient given surveys to complete POD #7 at home.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Discharge timing

Patients will be discharged home on the day of surgery as opposed to POD #1

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No