Breast Cancer Clinical Trial
— BIOSYMOfficial title:
BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices With Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction
NCT number | NCT05449691 |
Other study ID # | 315581 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2, 2023 |
Est. completion date | April 30, 2026 |
In this feasibility study, 60 women undergoing reconstruction will be randomly allocated to receive biological or synthetic mesh and followed for 6 months. The findings will tell us if patients and surgeons are comfortable with not being able to choose which mesh is used for the operation. In the larger surgical study, the investigators plan to measure patients' satisfaction with the reconstruction, patients' quality of life, complications from the operation and costs over 5 years.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | April 30, 2026 |
Est. primary completion date | April 30, 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Female age = 18 Women undergoing mastectomy and immediate one-stage mesh assisted implant breast reconstruction as standard treatment Exclusion Criteria: Revision reconstruction surgery Delayed reconstruction surgery |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospitals of Derby and Burton NHS Foundation Trust | Derby | |
United Kingdom | Castle Hill Hospital | Hull | |
United Kingdom | University Hospitals of Leicester NHS Trust | Leicester |
Lead Sponsor | Collaborator |
---|---|
University Hospitals of Derby and Burton NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinician acceptance | Proportion of eligible women offered the trial | 2 years | |
Primary | Patient acceptance | Proportion of women offered the trial who participate in the trial | 2 years | |
Primary | Recruitment rate | Number of patient recruited per year per site | 2 years | |
Primary | Compliance with allocated intervention | Number of patients not complying with randomisation allocation | 2 years |
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