Breast Cancer Clinical Trial
— PROM-QOfficial title:
Comparison of Patient Reported Outcome Measures in Patients Undergoing Pre Versus Sub-pectoral Implant Based Breast Reconstruction
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 breast reconstruction and current advances in surgical technology have led to increasing number of patients having implants placed above the pectoral muscle (pre-pectoral), rather than below it (sub-pectoral). This has important benefits for patients including shorter surgery time, quicker recovery, and avoidance of animation deformity (visible muscle twitching of the reconstructed breast) as the pectoral muscle is not divided to cover the implant. However, potential disadvantages include rippling effect as the implant is covered by the skin and subcutaneous tissue only, as well as potentially higher risk of capsule (scar tissue) formation. By utilising a validated questionnaire (BREAST-Q), we will assess for any difference in PROMs between the two groups of patients. The results will provide valuable information for future patients when making an informed decision about their reconstruction options. This questionnaire study will include consecutive patients undergoing mastectomy and immediate IBR for breast cancer as well as for risk reduction at Leeds Teaching Hospitals NHS Trust. The study participants will undergo either pre- or sub-pectoral IBR based on their informed discussion with the clinical team. This is a non-randomised observational study.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - Male or transgender - Mastectomy only with no reconstruction - Delayed reconstruction - Autologous reconstruction - Cognitive impairment or inability to provide informed consent |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Leeds Teaching Hospitals NHS Trust | Leeds | West Yorkshire |
Lead Sponsor | Collaborator |
---|---|
The Leeds Teaching Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare any difference in patient reported outcome measures in patients undergoing pre- versus sub-pectoral implant based breast reconstruction. | To measure the difference in BREAST-Q score in patients undergoing pre- versus sub-pectoral implant based breast reconstruction. We will compare psychosocial well-being, satisfaction with breasts, physical well-being, animation deformity, and patient experience with the clinical team. | Up to 12 months post-surgery |
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