None listed
Conditions
Brief summary
Breast conserving surgery and radiotherapy is currently considered as an effective treatment for early breast cancer. The goals of this treatment are to achieve local tumours control and survival rates equivalent to mastectomy while preserving the appearance of the breast. The cosmetic outcome of such treatment is very important for the psychological, social and sexual function of women. The role of this study is to evaluate the effects of intraoperative breast reshaping, in the context of a full range of breast volume excisions in association with radiotherapy, on the long-term (three year) cosmetic outcome after breast conservation surgery.
Interventions
Randomly selected patients who require breast conservation surgery and who have consented will be entered into the study. Patient numbers will be drawn from a box in theatre and this number will dictate either routine current surgical technique of wide local excision (control) or breast reshaping. In the breast reshaping, the breast tissue is mobilised superficially and deep from the skin and the pectoral muscles, respectively in order to close the defect (2/0 vicryl). Subsequently, deep dermal
Randomly selected patients who require breast conservation surgery and who have consented will be entered into the study. Patient numbers will be drawn from a box in theatre and this number will dictate either routine current surgical technique of wide local excision (control) or breast reshaping. In the breast reshaping, the breast tissue is mobilised superficially and deep from the skin and the pectoral muscles, respectively in order to close the defect (2/0 vicryl). Subsequently, deep dermal (2/0 vicryl) and skin sutures (3/0 monocryl subcuticular) are used to close the wound. The technique takes <30minutes. The wounds will be infiltrated with Bupivacaine local anaesthetic at a dose <2.0 mg/kg.
Sponsors
Kathryn Andrews
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Patients selected for breast conservation surgery for breast cancer after multidisiplinary decision and informed consent.
Exclusion criteria
Not requiring breast conservation surgery
Outcome results
None listed