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RCT Implant Based Breast Reconstruction

NCT04558138 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2025-11-05

No results posted yet for this 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.

Conditions

  • Mastectomy

Interventions

OTHER

Discharge timing

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Christodoulos Kaotzanis, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-20
Primary Completion
2024-01-16
Completion
2025-10-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04558138 on ClinicalTrials.gov