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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00827736

Enrollment

Registered

2009-01-23

Start date

2002-06-30

Completion date

2006-03-31

Last updated

2009-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Fissure

Keywords

anal fissure, fissura ani, botox, ISDN, Nitric oxide donor

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.

Interventions

PROCEDUREBotox

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

DRUGISDN ointment

application of ISDN 1% ointment 6 times a day

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
macroscopic healing of the fissure	4 months

Secondary

Measure	Time frame
complications	12 months
fissure recurrence	12 months
fissure related pain	12 months
costs	12 months

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026