Status:
COMPLETED
ERAS in Autologous Breast Reconstruction: A Pilot RCT
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
St. Joseph's Healthcare Hamilton
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 reconstruct...
Detailed Description
1.1 Primary research question To determine the feasibility of a randomized controlled trial comparing an Enhanced Recovery After Surgery (ERAS) protocol to conventional perioperative care for adult wo...
Eligibility Criteria
Inclusion
- Women of age 18 years or greater
- Able to understand and communicate in English
- Diagnosis of breast cancer or BRCA gene
- Undergoing (or previously had) unilateral or bilateral mastectomy
- Undergoing immediate or delayed DIEP breast reconstruction (unilateral or bilateral).
- Patients undergoing repeat breast reconstruction (secondary reconstruction) after a previously failed alloplastic or autologous reconstruction will be eligible to participate.
- Patients undergoing both DIEP and alloplastic reconstruction (e.g. DIEP reconstruction for one breast, alloplastic reconstruction for the other breast) will also be eligible to participate.
Exclusion
- Non-ambulatory at baseline
- Pregnant
- Unable to provide informed consent or unable to complete quality of life questionnaires due to mental capacity, cognitive impairment, or language barrier.
Key Trial Info
Start Date :
November 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04306003
Start Date
November 5 2019
End Date
June 30 2020
Last Update
July 29 2020
Active Locations (2)
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1
Juravinski Hospital
Hamilton, Ontario, Canada
2
St. Joseph's Healthcare
Hamilton, Ontario, Canada