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21 May 2012 
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Prospective randomised study of minimal invasive vs open surgery for treatment of benign breast lesions.
ISRCTN ISRCTN28820566
ClinicalTrials.gov identifier
Public title Prospective randomised study of minimal invasive vs open surgery for treatment of benign breast lesions.
Scientific title
Acronym N/A
Serial number at source N0084125093
Study hypothesis To evaluate comparative cosmetic outcome between open and minimal invasive surgery.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Surgery: Breast lesions
Participants - inclusion criteria 40 patients with benign breast legions will be recruited
Participants - exclusion criteria Does not match inclusion criteria
Anticipated start date 10/04/2003
Anticipated end date 01/12/2005
Status of trial Completed
Patient information material
Target number of participants 40
Interventions Randomised controlled trial (RCT) comparing:
1. Minimally invasive surgery
2. Open surgery
Primary outcome measure(s) Cosmetic outcomes
Secondary outcome measure(s) Not provided at time of registration
Sources of funding The North and South Bank Research and Development Consortium (UK)
Trial website
Publications
Contact name Mr  Phillip  Drew
  Address Academic Surgical Unit
Castle Hill Hospital
Castle Road
  City/town Cottingham
  Zip/Postcode HU16 5JQ
  Country United Kingdom
  Tel +44 (0)1482 875875
  Email
Sponsor Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
  Address The Department of Health,
Richmond House,
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)20 7307 2622
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.dh.gov.uk/Home/fs/en
Date applied 30/09/2004
Last edited 27/05/2010
Date ISRCTN assigned 30/09/2004
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