A multicentre randomised trial to assess the impact of the type 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 17 人开始时间: 2010年1月6日最近更新: 2022年4月19日

适应症

试验速览

•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

•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)

发起方

niversity Hospitals of Bristol NHS Foundation Trust (UK)