RCT Implant Based Breast Reconstruction

NCT04558138 | Completed DMC

• 2 other identifiers: 20-1055.ccP30CA046934
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastectomy

Keywords

Reconstruction

Outcome Measures

Primary Outcomes (6)

• Rate of post-operative complications surgical site infection

  Assessed by patient report

  Up to 30 Days

• Number of Participants with Post-operative hematoma

  Assessed by patient report

  Up to 30 Days

• Number of Participants with Post-operative blood clots

  Assessed by patient report

  Up to 30 Days

• Number of Participants with Post-operative emergency department visits

  Assessed by patient report

  Up to 30 Days

• Number of Participants with Post-operative hospital readmissions

  Assessed by patient report

  Up to 30 Days

• Number of Participants with Post-operative re-operation

  Assessed by patient report

  Up to 30 Days

Secondary Outcomes (6)

• Pain Score

  Up to 30 Days

• Opioid Consumption

  Post-Operative day 7

• Opioid adverse effects

  Up to 30 Days

• Quality of life perceptions: QoR-15

  Up to 30 Days

• Discharge perceptions

  Post-Operative day 7

Study Arms (2)

Discharge day of surgery

EXPERIMENTAL

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

Other: Discharge timing

Discharge post operative day 1

NO INTERVENTION

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

Interventions

Discharge timing OTHER

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

Discharge day of surgery

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• poorly controlled diabetes (HgbA1c \> 9)
• Not English or Spanish speaking

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Study Officials

• Christodoulos Kaotzanis, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: September 22, 2020
• Study Start: August 20, 2020
• Primary Completion: January 16, 2024
• Study Completion: October 13, 2025
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)