Breast cancer Cancer Malignant neoplasm of the breast
Conditions
Interventions
Patients will be allocated in a 1:1 ratio to either immediate autologous extended lattissimus dorsi (ALD) breast reconstruction or immediate implant assisted lattissimus dorsi (LDI) breast reconstruct
Sponsors
University Hospitals of Bristol NHS Foundation Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Any women requiring a mastectomy and electing to undergo latissimus dorsi breast reconstruction (LDBR) following a diagnosis of invasive primary breast cancer or ductal carcinoma in situ (DCIS) 2. Pre-operative evaluation of the breast and axilla suggest that post-operative radiotherapy is not anticipated according to local radiotherapy (RT) policy 3. Patient is technically suitable for an autologous extended LD procedure or agreeable to a reduction mammoplasty and planned contralateral reduction 4. Patient does not express a preference regarding procedure type 5. The capacity to understand the patient information sheet and ability to provide written informed consent 6. The capacity to understand and complete the self reported Health Related Quality of Life (HRQL) and General Nordic Questionnaire for Psychological and Social Factors at Work (QPS) questionnaires 7. Physical fitness as per the pre-operative evaluations (electrocardiogram [ECG], chest x-ray [CXR], blood biochemistry) 8. Aged between 25 and 75 years
Exclusion criteria
Exclusion criteria: 1. Prophylactic or risk-reducing surgery (i.e. no malignant or pre-malignant pathology such as lobular carcinoma in situ [LCIS]) 2. Previous radiotherapy to the breast 3. Bilateral synchronous pathology 4. Previous wide local excision (requiring completion mastectomy) 5. Loco-regional recurrence 6. Pregnancy as confirmed on blood tests or ultrasound examination 7. Evidence of distant metastases as diagnosed by chest X-ray, bone scan, liver ultrasound scan (USS) or computed tomography (CT) chest/abdomen and/or magnetic resonance imaging (MRI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The number of eligible women who accept randomisation and their subsequent treatment allocation 2. The rationale for women declining randomisation as assessed through the Patient Views on QUEST questionnaire (PVQ) 3. The perceptions of surgeons and breast care nurses regarding equipoise evidence relating to cosmetic appearance, complications and quality of life outcomes through Perceptions of Equipoise Evidence and Randomisation Survey (PEERS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Health related quality of life outcomes, measured at each of the follow-up assessments at 3, 6, 12, 24, 36, 48 and 60 months between allocated treatment groups | — |
Countries
England, United Kingdom
Outcome results
None listed