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

Onze Lieve Vrouwe Gasthuis

Status and phase: Completed; Phase 4

Conditions: Anal Fissure

Treatments: Drug: ISDN ointment; Drug: Placebo; Procedure: Botox

Study type: Interventional

Funder types: Other

Identifiers

NCT00827736

00.058

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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73 participants in 2 patient groups

Botox injection

Experimental group

Description:

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

Treatment:

Procedure: Botox

ISDN ointment

Active Comparator group

Description:

application of ISDN 1% ointment 6 times a day. injection of placebo into internal anal sphincter

Treatment:

Drug: Placebo

Drug: ISDN ointment

Procedure: Botox