RCT Implant Based Breast Reconstruction

Last updated: November 12, 2024
Sponsor: University of Colorado, Denver
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Mastectomy

Treatment

Discharge timing

Clinical Study ID

NCT04558138
20-1055.cc
P30CA046934
  • Ages 19-80
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who will undergo immediate, (unilateral or bilateral)implant-based breastreconstruction following mastectomy for breast cancer or prophylaxis at theUniversity of Colorado Anschutz Medical Campus and Highlands Ranch Campus.

  2. Patients undergoing sub-pectoral and pre-pectoral breast implant reconstructivetechniques will be both included.

  3. All adult (>18 years old), female patients who will undergo mastectomy for breastcancer or prophylaxis and immediate implant-based reconstruction who are able tocomplete 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

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 usedisorder, opioid use disodrer, cocaine use disorder, etc). Marijuana use will not beconsidered 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

Study Design

Total Participants: 123
Treatment Group(s): 1
Primary Treatment: Discharge timing
Phase:
Study Start date:
August 20, 2020
Estimated Completion Date:
January 05, 2026

Study 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.

Connect with a study center

  • University of Colorado Hospital

    Aurora, Colorado 80045
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.