The iBRA (implant breast reconstruction evaluation) study

Not Applicable

Completed

• Conditions: Implant-based breast reconstruction following mastectomy for breast cancer or risk reduction; Cancer

• Registration Number: ISRCTN37664281
• Lead Sponsor: niversity of Bristol (phase 3 only)

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30639093 results (added 16/01/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32252788 qualitative interview results (added 08/04/2020) 2016 Protocol article in https://pubmed.ncbi.nlm.nih.gov/27965859/ protocol (added 23/07/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32657919/ results (added 23/07/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33609398/ (added 16/11/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-04
• Study Completion: 2018-05-30
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 2108

Inclusion Criteria

1. Female patients
2. Undergoing immediate IBBR for malignancy or risk-reduction under the care of the breast or plastic surgeons

Exclusion Criteria

1. Women undergoing delayed breast reconstruction
2. Revisional surgery
3. Patients not willing or able to provide informed consent for the patient reported outcomes part of the study

Study & Design

• Study Type: Observational
• Study Design: Not specified