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ISRCTN
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ISRCTN97376902
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ClinicalTrials.gov identifier
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Public title
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The anal fistula PLUG versus the mucosal flap advancement for the treatment of perianal fistulas
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Scientific title
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Acronym
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PLUG
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Serial number at source
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N/A
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Study hypothesis
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The anal fistula plug is superior in the treatment of high transphincteric fistulas compared to the mucosal advancement flap.
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Ethics approval
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Approval received from the Medical Ethics Committee AMC, Amsterdam on the 23rd August 2006 (ref: MEC 06/204).
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Study design
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Multicentre, randomised, double blinded, active controlled, parallel group trial
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Countries of recruitment
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The Netherlands
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Disease/condition/study domain
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Perianal fistula
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Participants - inclusion criteria
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1.High anorectal fistula of cryptoglandular origin (transphincteric, upper 2/3 of the sphincter complex which is confined by the puborectal sling and the end of the anal canal)
2. Informed consent
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Participants - exclusion criteria
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1. Aged less than 18 years
2. Human Immunodeficiency Virus (HIV)-positive
3. Crohn's disease
4. Malignant cause
5. Tuberculosis
6. Hidradenitis suppurativa
7. Pilonidal sinus disease
8. No internal opening found during surgery
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Anticipated start date
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01/10/2006
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Anticipated end date
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01/10/2007
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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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60
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Interventions
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installation of the anal fistula plug versus mucosal flap.
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Primary outcome measure(s)
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1. Anorectal fistula closure rate
2. Continence
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Secondary outcome measure(s)
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1. Morbidity
2. Post-operative pain
3. Sick leave
4. Quality of life
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Sources of funding
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Academic Medical Centre (AMC) (The Netherlands)
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Trial website
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Publications
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Contact name
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Dr
J.F.M.
Slors
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Address
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Academic Medical Centre
Afd. Chirurgie
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City/town
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Amsterdam
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Zip/Postcode
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1105 AZ
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Country
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Netherlands
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Tel
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+31 (0)20 566 9111
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Email
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j.f.slors@amc.uva.nl
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Sponsor
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Academic Medical Centre (AMC) (The Netherlands)
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Address
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Department of Surgery
P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Sponsor website:
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http://www.amc.uva.nl#http://www.amc.uva.nl/
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Date applied
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16/07/2007
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Last edited
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27/07/2007
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Date ISRCTN assigned
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16/07/2007
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