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ISRCTN
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ISRCTN64721841
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial of laparoscopic versus open repair of inguinal hernia
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Added as of 22/05/2008:
To establish the safety, short term outcome, and theatre costs of transabdominal laparoscopic repair of inguinal hernia performed as day surgery.
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Ethics approval
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Not provided at time of registration
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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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Inguinal hernia
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Participants - inclusion criteria
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1. Primary, unilateral inguinal hernia
2. Aged less than 70 years
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Participants - exclusion criteria
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Previous major abdominal surgery
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Anticipated start date
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01/12/1992
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Anticipated end date
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30/06/1994
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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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125
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Interventions
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Laparoscopic or open repair of inguinal hernia
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Primary outcome measure(s)
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Added 16/04/2009:
1. Morbidity
2. Post-operative pain and use of analgesics
3. Quality of life
4. Theatre costs
Outcome was assessed by questionnaires administered to patients daily for 10 days and at six weeks post-operatively and by outpatient review at six weeks.
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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NHS Executive South East (UK)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/7580639
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Contact name
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Mr
Douglas
McWhinnie
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Address
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Milton Keynes General Hospital Trust
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City/town
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Milton Keynes
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Zip/Postcode
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M6 5AZ
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Country
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United Kingdom
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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16/04/2009
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Date ISRCTN assigned
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23/01/2004
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