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ERAS in Autologous Breast Reconstruction: A Pilot RCT

NCT04306003 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-07-29

No results posted yet for this study

Summary

Over 26,000 Canadian women are diagnosed with breast cancer each year and 1 in 3 patients undergo mastectomy. With an upward of 40% of breast cancer patients seeking post-mastectomy breast reconstruction (PMBR), there is a significant opportunity to improve the quality of perioperative care for breast reconstruction patients. Enhanced Recovery After Surgery (ERAS) is a multidisciplinary, multimodal, and evidence-based approach to perioperative care that safely reduces hospital length of stay and opioid use following colorectal surgery. ERAS recommendations have been proposed for women undergoing autologous PMBR who typically stay in hospital 4 to 5 days after surgery. However, the evidence to support ERAS in breast reconstruction is limited to observational studies compared to the numerous clinical trials in colorectal surgery. The goal of this study is to address this knowledge gap by evaluating the feasibility of conducting a RCT comparing ERAS to standard perioperative care.

Conditions

Interventions

OTHER

ERAS pathway

See ERAS pathway arm description.

OTHER

Standard Perioperative Care

See control arm description.

Sponsors & Collaborators

  • St. Joseph's Healthcare Hamilton

    collaborator OTHER

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Hyosuk Chin, MD · McMaster University

  • Marko Simunovic, MD · Hamilton Health Sciences Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-05
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT04306003 on ClinicalTrials.gov