ISRCTN92581226Completed未知
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 sites55 target enrollmentStarted: January 6, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 55
Study Overview
Brief Summary
2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25451179 results
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •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
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. 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
Investigators
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