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Trial registered on ANZCTR


Registration number
ACTRN12612000638831
Ethics application status
Approved
Date submitted
26/04/2012
Date registered
15/06/2012
Date last updated
15/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of breast oncoplastic reshaping on the long term cosmetic outcome after breast conservation surgery : A prospective randomised trial.
Scientific title
A prospective randomised trial assessing patients with breast cancer who have undergone breast conservation surgery to investigate the long term cosmetic outcome of oncoplastic reshaping.
Secondary ID [1] 280402 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 286379 0
Condition category
Condition code
Cancer 286620 286620 0 0
Breast
Surgery 286634 286634 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 284762 0
Treatment: Surgery
Comparator / control treatment
In the routine technique (control), deep dermal (2/0 vicryl) and skin stitches (3/0 monocryl subcuticular) are used to close the wound without attempting to close the defect in the breast tissue. The technique takes <30minutes.
Control group
Active

Outcomes
Primary outcome [1] 287033 0
Subjective assessment of cosmesis on a scale of 0 to 10.
Independent assessment by a panel (consists of two trained observers) and by the patient. There will be a live and a photographic assessment of the photograph taken on the previous outpatient visit. There will be an independent assessment for the breast size, breast shape and overall cosmesis using the following scale :
- Excellent cosmesis (9-10) : treated breast is almost identical to normal breast
- Good cosmesis (7-8) : slight difference
- Fair (5-6) : obvious diffference but no major deformity
- Poor (4 or less) : major distortion of the treated breast
Timepoint [1] 287033 0
Patient measurements and photographs taken prior to surgery. Patient questionnaire, photographs and independent assessment by a panel undertaken after surgery.
Primary outcome [2] 287045 0
Objective assessment of cosmesis
- All measurements will be assessed at each visit
- Distance from suprasternal notch to nipple (mm)
- Distance from mid-clavicular point to nipple (mm)
- Nipple to inframammary fold (mm)
- Nipple to midsternal line (mm)
- Base, height and breast projection (calliper) (mm)
- Breast retraction assessment as explained before.
Timepoint [2] 287045 0
At 3 month and every 6 month for three years
Photograph every 6 months
Primary outcome [3] 287260 0
Skin changes after radiotherapy
Independent assessment by a panel (consists of two trained observers) and by the patient. There will be a live and a photographic assessment of the photograph taken on the previous outpatient visit. There will be an independent assessment for breast skin pigmentation, telangiectasia, breast firmeness and oedema using the following scale :
- Nil (0)
- Mild (1-3)
- Moderate (4-6)
- Severe (7-10)
Timepoint [3] 287260 0
At 3 month and every 6 month for three years
Photograph every 6 months
Secondary outcome [1] 297267 0
Demographics: Patient's age, weight, height, BMI and side of the surgery,
Timepoint [1] 297267 0
Preoperative clinic/ prior to surgery.
Secondary outcome [2] 297764 0
Bra and cup size.
Timepoint [2] 297764 0
Preoperative clinic/ prior to surgery.
Secondary outcome [3] 297765 0
Grade of breast ptosis:
Grade I : nipple position above the inframammary fold line
Grade II : nipple position at the same level as the inframammary fold line
Grade III : nipple position below the inframammary fold line
Timepoint [3] 297765 0
Preoperative clinic/ prior to surgery.
Secondary outcome [4] 297766 0
4 Preoperative measurements (mm)
- Distance from suprasternal notch to nipple
- Distance from mid-clavicular point to nipple
- Nipple to inframammary fold
- Nipple to midsternal line
- Base, height and breast projection
Timepoint [4] 297766 0
Preoperative clinic/ prior to surgery.
Secondary outcome [5] 297767 0
The clinical tumour size (using callipers measured in mm) and tumour location
Timepoint [5] 297767 0
Preoperative clinic/ prior to surgery.
Secondary outcome [6] 297768 0
Distance from the closest edge of the tumour to nipple (mm)
Timepoint [6] 297768 0
Preoperative clinic/ prior to surgery.
Secondary outcome [7] 297769 0
Mammographic assessment
- Tumour size (mm)
- Closest edge of the tumour to nipple (mm)
- Estimated breast volume.
- Estimated percentage volume required for excision (EPVE).
Timepoint [7] 297769 0
Preoperative clinic/ prior to surgery.
Secondary outcome [8] 297770 0
Neoadjuvant treatment, either chemotherapy or hormonal therapy (all measurements will be assessed again after neoadjuvant treatment and prior to surgery)
Timepoint [8] 297770 0
Postoperative clinic.
Secondary outcome [9] 297771 0
Surgery:
- Type of procedure: wide local excision (WLE), wire guided or U/S guided WLE
- Time start of the breast reshaping procedure (24 hour)
- Length of the incision (mm)
- Skin ellipse (if performed) dimensions (mm): length (north to south), width (east to west)
- Dry weight of the resected tissue (g)
- Dimensions of the resected specimen (mm): Length (north to south), width (east to west), and thickness (skin to pectoral muscle or the deep margin of the specimen)
- Size of the defect in the breast following excision (mm): length (north to south), width (east to west) and thickness (skin to pectoral muscle or the deep margin of the specimen)
- Time at completion of breast reshaping (24 hour)
- Time starting and finishing surgery (24 hour)
Timepoint [9] 297771 0
Immediate postoperatively
Secondary outcome [10] 297772 0
Postoperative complications
- Infection
- Haematoma
- Seroma requiring aspiration
- Breast skin necrosis
- Breast lymphoedema
Timepoint [10] 297772 0
Postoperative clinic.
Secondary outcome [11] 297773 0
Details of re-excision of margins
- Date of re-excision
- Skin ellipse diamentions (length 'north to south' and width 'east to west')
- Margin excised (superior, inferior, medial or lateral)
- Dry weight of the resected tissue (g)
- Dimentions of the resected tissue (mm) (length 'north to south', width 'east to west' and thickness 'skin to pectoral muscle or the deep margin of the specimen')
Timepoint [11] 297773 0
Postoperative clinic.
Secondary outcome [12] 297774 0
Details of radiotherapy
- Date of start and finish of treatment
- Total dose
- Number of fractions
- Boost dose to tumour bed (total dose and number of fractions)
Timepoint [12] 297774 0
Postoperative clinic.
Secondary outcome [13] 297775 0
Details of chemotherapy
- Date of start and finish of treatment
- Type of chemotherapy
- Number of cycles
- Infective complications of the breast
Timepoint [13] 297775 0
Postoperative clinic.
Secondary outcome [14] 297776 0
Patient satisfaction questionnaire using the body image scale.
Timepoint [14] 297776 0
Postoperative clinic.

Eligibility
Key inclusion criteria
Patients selected for breast conservation surgery for breast cancer after multidisiplinary decision and informed consent.
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Not requiring breast conservation surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients under an identified Breast Surgeon's care who require breast conservation surgery will be asked to join the trial. The study will be discussed with them in detail and a patient information sheet will be provided. Patients will be asked to sign a separate consent form to participate in the study. Patients who agree to participate in the trial will be randomised to either having breast reshaping or the routine surgical technique (control) as disscused before. A sealed envelope containing a number is drawn from a box in theatre and this number will dictate either routine current surgical technique of wide local excision (control) or breast reshaping.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation performed by using a sealed envelope containing a number is drawn from a box in theatre and this number will dictate either routine current surgical technique of wide local excision (control) or breast reshaping.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The procedure of breast reshaping will be timed. Patients will then have axillary surgery according to the recognised unit’s protocol. In both groups, the wounds will be infiltrated with Bupivacaine (<2.0 mg/kg). Patients will be discharged home as appropriate.

All patients will be seen in the outpatient clinic at two weeks postoperatively and thereafter at three months, and every 6 months for three years for both oncological and cosmetic follow up. The oncology treatment and further follow-up will be according to the unit’s protocol and details of radiotherapy and all adjuvant treatment will be recorded.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4283 0
United Kingdom
State/province [1] 4283 0
Norfolk

Funding & Sponsors
Funding source category [1] 285180 0
Self funded/Unfunded
Name [1] 285180 0
Nil
Address [1] 285180 0
Nil
Country [1] 285180 0
United Kingdom
Primary sponsor type
Individual
Name
Kathryn Andrews
Address
Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
Country
United Kingdom
Secondary sponsor category [1] 284037 0
None
Name [1] 284037 0
Nil
Address [1] 284037 0
Nil
Country [1] 284037 0

Ethics approval
Ethics application status
Approved

Summary
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.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 34116 0
Address 34116 0
Country 34116 0
Phone 34116 0
Fax 34116 0
Email 34116 0
Contact person for public queries
Name 17363 0
Maged Hussien MD, FRCS (Gen. Surg)
Address 17363 0
Breast Surgery Unit
Norfolk and Norwich University Hospitals
Level 3 west,
Colney Lane
Norwich
NR4 7UY
Country 17363 0
United Kingdom
Phone 17363 0
+44 01603 286286
Fax 17363 0
+44 01603 286286
Email 17363 0
maged.hussien@nnuh.nhs.uk
Contact person for scientific queries
Name 8291 0
Maged Hussien MD, FRCS (Gen. Surg)
Address 8291 0
Breast Surgery Unit
Norfolk and Norwich University Hospitals
Level 3 west,
Colney Lane
Norwich
NR4 7UY
Country 8291 0
United Kingdom
Phone 8291 0
+44 01603 286286
Fax 8291 0
+44 01603 287211
Email 8291 0
maged.hussien@nnuh.nhs.uk

No information has been provided regarding IPD availability
Summary results
No Results