NCT00827736

Comparison of Treatment Success of Botox Injection in the Internal Sphincter Versus Isosorbidedinitrate Ointment in Patients With an Anal Fissure

Botulin Toxin Versus Isosorbidedinitrate Ointment in Treatment Anal Fissure; A Prospective, Blinded, Randomized Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Onze Lieve Vrouwe Gasthuis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anal Fissure

Interventions

Type	Name	Description
PROCEDURE	Botox	injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline.
DRUG	ISDN ointment	application of ISDN 1% ointment 6 times a day
DRUG	Placebo	Injection of placebo into internal anal sphincter (ISDN ointment arm) Applied to the anoderm six times a day (Botox injection arm)

Timeline

• Start date: 2002-06-01
• Primary completion: 2006-03-01
• Completion: 2006-03-01
• First posted: 2009-01-23
• Last updated: 2009-01-23

Locations

1 site across 1 country: Netherlands