Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000343000
Ethics application status
Not yet submitted
Date submitted
8/04/2010
Date registered
29/04/2010
Date last updated
29/04/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of abdominoplasty on quality of life and self esteem
Scientific title
In patients having had abdominoplasty is there a difference in post vs. presurgical qualilty of life and self esteem
Secondary ID [1] 1611 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of Life in Abdominoplasty patients 257189 0
Condition category
Condition code
Surgery 257333 257333 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A standard abdominplasty procedure is performed in general anaesthesia. The operation may include liposuction. Skin and subcutaneous tissue between the umbilical level and and the pubic region is incised and removed. The upper skin flap is centrally undermined and sutured to the caudal wound edge. The procedure takes approx. 2 h. The procedure is a one-off treatment.
Intervention code [1] 241189 0
Treatment: Surgery
Comparator / control treatment
Preoperative condition
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240672 0
Quality of life measured by Short Form 36 (SF-36), Derriford Appearance Scale 24 (DAS24) and Multidimensional Body Self Relations Questionnaire (MBSRQ)
Timepoint [1] 240672 0
Each patient is asked to participate in a single study consultation 6-24 months post operatively.
Primary outcome [2] 240673 0
Visual (based on standardized photos) evaluation of operative result
Timepoint [2] 240673 0
Photos are taken at Timepoint 1 (no extra consultation).
Secondary outcome [1] 257311 0
nil
Timepoint [1] 257311 0
nil

Eligibility
Key inclusion criteria
Abdominoplasty patients operated at our
department
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Body Mass Index (BMI) >33
Large hernias

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
75 consequitive patiens who have had abdominoplasty at our department will be sent an invitation to participate in the study. These patient have been offered public funded abdominoplasty due to gross abdominal skin surplus and ailments like intertrigo, pain and infection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment outside Australia
Country [1] 1963 0
Norway
State/province [1] 1963 0

Funding & Sponsors
Funding source category [1] 256784 0
Self funded/Unfunded
Name [1] 256784 0
Country [1] 256784 0
Norway
Primary sponsor type
Individual
Name
Bjorn M. Hokland
Address
Bjorn M. Hokland, MD, PhD, Dept Plastic and Reconstructive Surgery, Oslo University Hospital, Ulleval, 0407 Oslo
Country
Norway
Secondary sponsor category [1] 256060 0
None
Name [1] 256060 0
Address [1] 256060 0
Country [1] 256060 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258807 0
Regional Ethics Commitee South East
Ethics committee address [1] 258807 0
Post Box 1130 Blindern, 0318 Oslo, Norway
Ethics committee country [1] 258807 0
Norway
Date submitted for ethics approval [1] 258807 0
08/04/2010
Approval date [1] 258807 0
Ethics approval number [1] 258807 0

Summary
Brief summary
In Norway patients may be offered publicly funded abdominoplasty when there is a large skin overhang combined with severe skin infection. The aim of the study is to investigate the effect of operative treatment on Quality of Life and self esteem.
Trial website
No trial wesite.
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30095 0
Address 30095 0
Country 30095 0
Phone 30095 0
Fax 30095 0
Email 30095 0
Contact person for public queries
Name 13342 0
Bjorn M. Hokland
Address 13342 0
Dept Plast Rec Surgery, Oslo University Hospital, Ulleval, 0407 Oslo, Norway
Country 13342 0
Norway
Phone 13342 0
0047 22 11 80 80
Fax 13342 0
0047 22 11 95 58
Email 13342 0
[email protected]
Contact person for scientific queries
Name 4270 0
Bjorn M. Hokland
Address 4270 0
Dept Plast Rec Surgery, Oslo University Hospital, Ulleval, 0407 Oslo, Norway
Country 4270 0
Norway
Phone 4270 0
0047 22 11 80 80
Fax 4270 0
Email 4270 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.