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

Onze Lieve Vrouwe Gasthuis73 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Anal Fissure

Interventions

BotoxPROCEDURE

injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline.

ISDN ointmentDRUG

application of ISDN 1% ointment 6 times a day

PlaceboDRUG

Injection of placebo into internal anal sphincter (ISDN ointment arm) Applied to the anoderm six times a day (Botox injection arm)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, Netherlands

Outcomes

Primary Outcomes

macroscopic healing of the fissure

Time frame: 4 months

Secondary Outcomes

complications

Time frame: 12 months

fissure recurrence

Time frame: 12 months

fissure related pain

Time frame: 12 months

costs

Time frame: 12 months

Data from ClinicalTrials.gov

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