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Comparison of Botox versus Isosorbidedinitrate Ointment in the treatment of an anal fissure.


- candidate number5154
- NTR NumberNTR1628
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jan-2009
- Secondary IDs00.058 
- Public TitleComparison of Botox versus Isosorbidedinitrate Ointment in the treatment of an anal fissure.
- Scientific TitleBotulin Toxin versus Isosorbidedinitrate Ointment in Treatment Anal Fissure; A Prospective, Blinded, Randomized Trial.
- ACRONYMN/A
- hypothesisBotulin toxin will show a better healing rate after 4 months of treatment than Isosorbidedinitrate Ointment (90% vs 65%).
- 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
- InterventionsTreatment in group I consisted of injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline16. In addition, they were given a placebo ointment to apply to the anoderm six times a day Patients in group II received a placebo injection and ISDN 1% ointment.
- Primary outcomeMacroscopic healing of the fissure at 4 months.
- Secondary outcome1. Fissure related pain;
2. Treatment induced complications;
3. Fissure recurrence and costs.
- TimepointsEvaluation of complaints related to the anal fissure was done before treatment and during follow up at 1, 2, 4, 6 and 12 months post treatment using a questionnaire.
- 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)
European Union
- PublicationsN/A
- Brief summaryBackground:
Nitric oxide donors like Isosorbide Dinitrate (ISDN) are still considered the first choice of treatment for anal fissures. After a number of reports on the successful treatment of anal fissures with Botulin toxin (BT), this randomized blinded trial was conducted to compare BT with ISDN in the treatment of chronic anal fissures.
Methods:
Patients were randomized into two groups. Group I patients received an injection of BT in the internal anal sphincter (IAS) and a placebo ointment, whereas group II patients received a placebo injection and ISDN ointment. The primary endpoint was macroscopic healing of the fissure after 4 months.
- Main changes (audit trail)
- RECORD13-jan-2009 - 9-sep-2009


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