A multicentre randomised trial to assess the impact of the timing of breast reconstruction on quality of life following mastectomy

niversity Hospitals of Bristol NHS Foundation Trust (UK)0 个研究点目标入组 55 人开始时间: 2010年1月6日最近更新: 2022年11月7日

适应症

试验速览

•1. 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. Technically suitable for a stage delayed autologous extended tissue-based latissimus dorsi (LD) procedure (this includes patients agreeable to a Wise or central reduction pattern reconstruction and a planned contralateral symmetrisation procedure if there is not sufficient volume to reconstruct the breast to its native size)
•3. Pre-operative evaluation of the breast and axilla suggest that post-operative radiotherapy (RT) is anticipated according to local RT policy
•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 report 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

•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. Loco-regional recurrence
•5. Previous wide local excision requiring completion mastectomy
•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 magnetic resonance imaging (MRI)
•8. Previous malignancy except basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin
•9. Significant other clinical risk factors and co-morbidities e.g. body mass index (BMI), diabetes, smoker according to local policy

发起方

niversity Hospitals of Bristol NHS Foundation Trust (UK)