Clinical Trial: Comparison of Treatment Success of Botox Injection in the Internal Sphincter Versus Isosorbidedinitrate Ointment in Patients With an Anal Fissure
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Botulin Toxin Versus Isosorbidedinitrate Ointment in Treatment Anal Fissure; A Prospective, Blinded, Randomized Trial
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 Summary:
Sponsor: Onze Lieve Vrouwe Gasthuis
Current Primary Outcome: macroscopic healing of the fissure [ Time Frame: 4 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- complications [ Time Frame: 12 months ]
- fissure recurrence [ Time Frame: 12 months ]
- fissure related pain [ Time Frame: 12 months ]
- costs [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Onze Lieve Vrouwe Gasthuis
Dates:
Date Received: January 20, 2009
Date Started: June 2002
Date Completion:
Last Updated: January 22, 2009
Last Verified: January 2009
