Comparison of Treatment Success of Botox Injection in the Internal Sphincter Versus Isosorbidedinitrate Ointment in Patients With an Anal Fissure
Information source: Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anal Fissure
Intervention: Botox (Procedure); ISDN ointment (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Onze Lieve Vrouwe Gasthuis Official(s) and/or principal investigator(s): Michael Gerhards, MD, Study Director, Affiliation: Onze Lieve Vrouwe Gasthuis
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.
Clinical Details
Official title: Botulin Toxin Versus Isosorbidedinitrate Ointment in Treatment Anal Fissure; A Prospective, Blinded, Randomized Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: macroscopic healing of the fissure
Secondary outcome: complicationsfissure recurrence fissure related pain costs
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Onze Lieve Vrouwe Gasthuis, Amsterdam, Noord Holland 1090 HM, Netherlands
Additional Information
Starting date: June 2002
Last updated: January 22, 2009
|