PROM comparison in pre- vs. sub-pectoral implant breast reconstruction
Research type
Research Study
Full title
Comparison of patient reported outcome measures in patients undergoing pre- versus sub-pectoral implant based breast reconstruction
IRAS ID
283017
Contact name
Baek Kim
Contact email
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
This study is for breast patients and the objective is to compare patient reported outcome measures (PROMs) in patients undergoing mastectomy and immediate implant 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 wish to assess for any difference in PROMs between the two groups of patients. The usage of routine PROMs collection has been recommended for all patients undergoing reconstructive surgery by the Association of Breast Surgery/British Association of Plastic Reconstructive and Aesthetic Surgeons oncoplastic breast reconstruction guideline.
The results will provide valuable information for future patients when making an informed decision about their reconstruction options. This questionnaire study will included all consecutive patients undergoing mastectomy and immediate IBR for breast cancer as well as for risk reduction at Leeds Teaching Hospitals NHS Trust. These patients will undergo either pre- or sub-pectoral IBR based on their informed discussion with the individual surgeons. The study conducted will have no influence in this decision making (i.e. non-randomised). The patients will be asked to complete the BREAST-Q questionnaire prior to surgery, at 2 weeks, as well as at 3 and 12 months post-surgery. Patients are followed up (face-to-face or telephone) at these time points as part of standard clinical care.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
20/EE/0206
Date of REC Opinion
19 Nov 2020
REC opinion
Further Information Favourable Opinion