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ISRCTN
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ISRCTN51268626
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ClinicalTrials.gov identifier
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Public title
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Quality of minor surgery carried out in primary or secondary care: population based randomised controlled equivalence trial
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Scientific title
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A prospective randomised comparison of minor surgery in primary and secondary care
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Acronym
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MiSTIC (Minor Surgery Trial In the Community)
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Serial number at source
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HTA 95/25/03
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Study hypothesis
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Increasingly with the move towards a "primary care led NHS" services previously provided within hospitals are being provided within primary care settings. One such service is minor surgery. Although minor surgery is widely practised in primary care it has not been subjected to critical analysis in a randomised study in terms of its safety, quality and cost effectiveness. This study is a prospective, randomised controlled trial comparing the treatment of minor surgical conditions in primary and secondary care in terms of these variables.
Please note that the target number of participants was added as of 02/12/2008.
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Ethics approval
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South and West Regional Research Ethics Committee, approved on 06/10/1999 (ref: 092/99)
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Lesions requiring minor surgery (predominantly skin)
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Participants - inclusion criteria
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Inclusion criteria amended as of 02/12/2008:
All patients (both genders, no age limits) with one of a range of conditions amenable to minor surgery who were considered suitable for treatment by a participating GP or one of their partners. The study focuses on four categories of minor surgical treatment; excisions, incisions, aspirations and "other", including removal of foreign bodies.
Previous inclusion criteria:
Patients requiring minor surgery.
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Participants - exclusion criteria
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Added as of 02/12/2008:
1. Patients whom operating doctor considered too complex for treatment in primary care
2. Patients requiring cautery
3. Patients requiring injections for the treatment of painful joints
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Anticipated start date
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01/05/1999
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Anticipated end date
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30/04/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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490
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Interventions
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Interventions amended as of 02/12/2008:
Elective minor surgeries in the categories described in the participants inclusion criteria field, delivered either in primary care, by the patient's own GP or by referral to a primary care colleague, or in hospital, by either surgeons or dermatologists at a variety of grades.
Previous interventions:
Quality of surgery performed in primary care vs surgery performed in hospital
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Primary outcome measure(s)
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Primary outcome measures amended as of 02/12/2008:
Quality of treatment measured using cosmetic results of surgery.
Previous primary outcome measures:
Safety, quality and cost effectiveness.
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Secondary outcome measure(s)
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Added as of 02/12/2008:
1. Extent to which samples were sent for histology
2. Completeness of excision of malignant lesions
3. Patient satisfaction with aspects of care
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18505669
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Contact name
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Dr
Steve
George
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Address
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University of Southampton Clinical Trials Unit
Mailpoint 131
Southampton General Hospital
Tremona Road
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City/town
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Southampton
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Zip/Postcode
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SO16 6YD
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Country
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United Kingdom
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Tel
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+44 (0)23 8079 6533
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Fax
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+44 (0)23 8079 6529
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Email
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pluto@soton.ac.uk
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Sponsor
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University of Southampton (UK)
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Address
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Highfield
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City/town
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Southampton
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Zip/Postcode
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SO17 1BJ
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Country
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United Kingdom
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Tel
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+44 (0) 23 8059 5000
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Fax
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+44 (0)23 8059 3939
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Email
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rgoinfo@soton.ac.uk
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Sponsor website:
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http://www.soton.ac.uk/
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Date applied
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25/04/2003
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Last edited
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21/08/2009
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Date ISRCTN assigned
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25/04/2003
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