Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000040662
Ethics application status
Not yet submitted
Date submitted
6/01/2014
Date registered
16/01/2014
Date last updated
16/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient Satisfaction Following Breast Reduction
Scientific title
Patient Satisfaction Following Breast Reduction Surgery – Comparison of Inferior Pedicle Wise Pattern and Superomedial pedicle Hall-Findlay Techniques
Secondary ID [1] 283857 0
Nil
Universal Trial Number (UTN)
U1111-1151-8741
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Reduction 290835 0
Condition category
Condition code
Surgery 291200 291200 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Inferior Pedicle Wise Pattern Breast Reduction; technique for bilateral breast reduction surgery, based on inferior pedicle. Approximate duration of surgery 3 hours. Previous reports suggest this technique results in better preservation of nipple sensation, but has greater incidence of breast 'bottoming out' and greater scar burden.
Intervention code [1] 288535 0
Treatment: Surgery
Comparator / control treatment
Superomedial Pedicle Hall-Findlay Breast Reduction: technique for bilateral breast reduction, based on superomedial pedicle. Approximate duration of surgery 3 hours. Previous reports suggest this technique results in reduced incidence of 'bottoming out' and has smaller scar, but has reduced nipple sensation, and is more likely to require revision.
Control group
Active

Outcomes
Primary outcome [1] 291190 0
Patient satisfaction, as measured using Breast Q questionnaire (validated pre- and post-operative questionnaire for use in breast surgery patients).
Timepoint [1] 291190 0
3 and 6 months post-operatively
Secondary outcome [1] 306207 0
Cosmetic outcome, as measured using clinical photography (in accordance with Peninsula Health clinical photgraphy guidelines). Cosmetic outcome will be assessed by independant, blinded plastic surgeons using the recognised grading system developed by Strasser et al (Plast Reconstr Surg 1999; 104(7): 2282-5.
Timepoint [1] 306207 0
3 and 6 months post-operatively

Eligibility
Key inclusion criteria
Women undergoing elective reduction mammoplasty at Peninsula Health between 03/02/2014 and 3/2/2018
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients will be excluded from the study if they have had previous breast surgery or radiotherapy, if they are unable to complete the questionnaire, if they have a BMI >35, if they are planned to have >1000g/breast removed, if they require free nipple grafting, if they require unilateral reduction, if they are <18yo, if they are pregnant, or if they are smokers or quit less than 6 weeks prior to their procedure.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288505 0
Self funded/Unfunded
Name [1] 288505 0
Country [1] 288505 0
Primary sponsor type
Hospital
Name
Peninsula Health
Address
Frankston Hospital
2 Hastings Rd
Frankston
Vic
3199
Country
Australia
Secondary sponsor category [1] 287210 0
None
Name [1] 287210 0
Address [1] 287210 0
Country [1] 287210 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290364 0
Peninsula Health
Ethics committee address [1] 290364 0
Ethics committee country [1] 290364 0
Australia
Date submitted for ethics approval [1] 290364 0
17/01/2014
Approval date [1] 290364 0
Ethics approval number [1] 290364 0
HREC/13/PH/33

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45338 0
Mr David Hunter-Smith
Address 45338 0
Frankston Hospital
2 Hastings Rd
Frankston
Vic
3199
Country 45338 0
Australia
Phone 45338 0
+61397847777
Fax 45338 0
Email 45338 0
[email protected]
Contact person for public queries
Name 45339 0
Daniel Reilly
Address 45339 0
Frankston Hospital
2 Hastings Rd
Frankston
Vic
3199
Country 45339 0
Australia
Phone 45339 0
+61438212661
Fax 45339 0
Email 45339 0
[email protected]
Contact person for scientific queries
Name 45340 0
Daniel Reilly
Address 45340 0
Frankston Hospital
2 Hastings Rd
Frankston
Vic
3199
Country 45340 0
Australia
Phone 45340 0
+61438212661
Fax 45340 0
Email 45340 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.