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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR994 |
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Date of registration:
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07/06/2007 |
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Primary sponsor: |
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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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The Anal Fistula Plug versus the mucosal flap advancement for the treatment of Perianal Fistulas. - PLUG |
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Date of first enrolment:
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1/10/2006 |
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Target sample size:
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60 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=994 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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J.F.M.
Slors |
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Address:
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AMC, Afd. Chirurgie, Meibergdreef 9
1105 AZ
Amsterdam
The Netherlands |
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Telephone:
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+3120-5669111 |
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Email:
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j.f.slors@amc.uva.nl |
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Affiliation:
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Name:
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J.F.M.
Slors |
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Address:
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AMC, Afd. Chirurgie, Meibergdreef 9
1105 AZ
Amsterdam
The Netherlands |
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Telephone:
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+3120-5669111 |
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Email:
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j.f.slors@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. High anorectal fistula of cryptoglandular origin (transsfincteric, upper 2/3 of the sfinctercomplex which is confined by the puborectal sling and the end of the anal canal);
2. Informed consent.
Exclusion criteria: 1. Age<18 years;
2. 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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Perianal fistula
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Intervention(s)
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Installation of the anal fistula plug.
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Primary Outcome(s)
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1. Anorectal fistula closure rate;
2. Continence.
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Secondary Outcome(s)
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1. Morbidity;
2. Post-operative pain;
3. Sick leave;
4. Quality of life.
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Secondary ID(s)
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ISRCTN97376902
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N/A
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Source(s) of Monetary Support
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Academic Medical Center (AMC), Department of Surgery
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