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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?


- candidate number5063
- NTR NumberNTR1614
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jan-2009
- Secondary IDs31011972 
- Public TitleInjection with Botox in the anal sphicnter versus treatment with isosorbidedinitrate ointment for patients with an anal fissure. what is the most successful treatment?
- Scientific TitleBotulin Toxin versus Isosorbidedinitrate Ointment in Treatment Anal Fissure; A Prospective, Blinded, Randomized Trial.
- ACRONYMN/A
- hypothesisTreatment with Botox will give a better healing rate for anal fissures compared to treatment with isosorbidedinitrate ointment.
- Healt Condition(s) or Problem(s) studiedAnal fissure
- Inclusion criteriaAll consecutive patients over the age of 18 with a chronic anal fissure presenting to our surgical outpatient clinic.
- Exclusion criteria1. Pregnancy;
2. previous anal surgery;
3. Crohn’s disease;
4. systemic causes of an anal fissure.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2002
- planned closingdate1-mrt-2006
- Target number of participants86
- Interventionsgroup 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.
- Primary outcomeMacroscopic healing of the fissure at 4 months.
- Secondary outcome1. Fissure related pain;
2. treatment induced complications;
3. fissure recurrence;
4. costs.
- Timepoints1, 2, 4, 6 and 12 months.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES S. Festen
- CONTACT for SCIENTIFIC QUERIES S. Festen
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD8-jan-2009 - 8-feb-2009


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