Comparison of Treatment Success of Botox Injection in the Internal Sphincter Versus Isosorbidedinitrate Ointment in Patients With an Anal Fissure
- Registration Number
- NCT00827736
- Lead Sponsor
- Onze Lieve Vrouwe Gasthuis
- Brief Summary
The standard treatment of anal fissure in the netherlands (ISDN ointment) is being compared to a relatively new treatment (injection of Botox in the internal anal sphincter). The study hypothesis is that after 4 months, Botox has healed more patients than ISDN. The comparison is done blinded for the surgeon and the patient.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
Inclusion Criteria
- all consecutive patients over the age of 18 with a chronic anal fissure presenting to our surgical outpatient clinic
Exclusion Criteria
- pregnancy
- previous anal surgery
- Crohn's disease
- systemic causes of an anal fissure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Botox injection Botox injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline. In addition, a placebo ointment has to be applied to the anoderm six times a day ISDN ointment Botox application of ISDN 1% ointment 6 times a day. injection of placebo into internal anal sphincter ISDN ointment ISDN ointment application of ISDN 1% ointment 6 times a day. injection of placebo into internal anal sphincter ISDN ointment Placebo application of ISDN 1% ointment 6 times a day. injection of placebo into internal anal sphincter
- Primary Outcome Measures
Name Time Method macroscopic healing of the fissure 4 months
- Secondary Outcome Measures
Name Time Method complications 12 months fissure recurrence 12 months fissure related pain 12 months costs 12 months
Trial Locations
- Locations (1)
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Noord Holland, Netherlands