Status:
UNKNOWN
Comparison of Patient Reported Outcome Measures Using the BREAST-Q Questionnaire in Patients Undergoing Pre Versus Sub-pectoral Implant Based Immediate Breast Reconstruction.
Lead Sponsor:
The Leeds Teaching Hospitals NHS Trust
Conditions:
Breast Disease
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
The PROM Q study aims to compare patient reported outcome measures (PROMs) in patients undergoing mastectomy and immediate implant based breast reconstruction (IBR). This is the commonest form of brea...
Detailed Description
Patients who undergo implant based immediate breast reconstruction (IBR) are offered an option of pre- versus sub-pectoral breast reconstruction. Both approaches are well established and have proven s...
Eligibility Criteria
Inclusion
- Skin or nipple sparing mastectomy with immediate implant based reconstruction for breast cancer or for risk reduction
- Unilateral or bilateral mastectomy
- Implant or expander based immediate reconstruction
- Able to read and understand questionnaire in English
Exclusion
- Male or transgender
- Mastectomy only with no reconstruction
- Delayed reconstruction
- Autologous reconstruction
- Cognitive impairment or inability to provide informed consent
Key Trial Info
Start Date :
September 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04842240
Start Date
September 1 2019
End Date
December 1 2022
Last Update
April 13 2021
Active Locations (1)
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1
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom, LS9 7TF