Status:
UNKNOWN
Restore-B: A Trial Comparing Prepectoral Implant-based Breast Reconstruction With and Without Mesh
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Breast Cancer
Risk Reduction
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The goal of this feasibility randomised controlled clinical trial (RCT) is to compare mesh-assisted to no-mesh pre-pectoral implant based immediate breast reconstruction in women undergoing mastectomy...
Detailed Description
Trial Design: Restore-B is a prospective, multicentre parallel 2-armed single-blinded randomised controlled feasibility trial comparing no-mesh to mesh- assisted immediate implant-based prepectoral b...
Eligibility Criteria
Inclusion
- Women \> 18 years
- Participant is able and willing to give informed consent for participation in the trial
- Eligible for immediate prepectoral implant-based breast reconstruction with implant or expander with mesh (biologic or synthetic) for cancer treatment or risk reduction surgery.
- In the Investigator's opinion, can comply with all trial requirements.
Exclusion
- The participant may not enter the trial if any of the following apply:
- Participant is pregnant, lactating or planning pregnancy during the trial
- Patient refusal
- Delayed breast reconstruction post simple mastectomy
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06112977
Start Date
November 1 2023
End Date
February 1 2025
Last Update
November 2 2023
Active Locations (1)
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1
Surigcal Intervention Trials Unit (SITU), Nuffield Department of Surgical Sciences, University of Oxford
Oxford, Oxfordshire, United Kingdom, OX3 9DU