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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: |
NTR1614 |
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Date of registration:
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08/01/2009 |
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Primary sponsor: |
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Public title:
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Injection with Botox in the anal sphicnter versus treatment with isosorbidedinitrate ointment for patients with an anal fissure. what is the most successful treatment?
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Scientific title:
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Botulin Toxin versus Isosorbidedinitrate Ointment in Treatment Anal Fissure;
A Prospective, Blinded, Randomized Trial.
- N/A |
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Date of first enrolment:
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1/6/2002 |
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Target sample size:
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86 |
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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=1614 |
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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: Placebo; 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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S.
Festen |
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Address:
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Onze Lieve Vrouwe Gasthuis, Oosterpark 9
Amsterdam
The Netherlands |
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Telephone:
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+31 (0) 20 5999111 |
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Email:
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s.festen@olvg.nl |
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Affiliation:
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Name:
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S.
Festen |
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Address:
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Onze Lieve Vrouwe Gasthuis, Oosterpark 9
Amsterdam
The Netherlands |
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Telephone:
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+31 (0) 20 5999111 |
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Email:
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s.festen@olvg.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: All consecutive patients over the age of 18 with a chronic anal fissure presenting to our surgical outpatient clinic.
Exclusion criteria: 1. Pregnancy;
2. previous anal surgery;
3. Crohn?s disease;
4. systemic causes of an anal fissure.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Anal fissure
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Intervention(s)
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group I: Injection of 2x 10u botulin toxin in internal anal sphincter and application of placebo ointment 6 times daily.
group II: application of isosorbidedinitrate ointment 6 times daily and injection of placebo in internal anal sphincter.
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Primary Outcome(s)
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Macroscopic healing of the fissure at 4 months.
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Secondary Outcome(s)
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1. Fissure related pain;
2. treatment induced complications;
3. fissure recurrence;
4. costs.
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Source(s) of Monetary Support
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