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

Anal Fissure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827736
• Other study ID #: 00.058
• Status: Completed
• Phase: Phase 4
• First received: January 20, 2009
• Last updated: January 22, 2009
• Start date: June 2002
• Est. completion date: March 2006

Study information

• Verified date: January 2009
• Source: Onze Lieve Vrouwe Gasthuis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Fissure
• Fissure in Ano

Intervention

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

Locations

Country	Name	City	State
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam	Noord Holland

Sponsors (1)

Lead Sponsor	Collaborator
Onze Lieve Vrouwe Gasthuis

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Brisinda G, Maria G, Bentivoglio AR, Cassetta E, Gui D, Albanese A. A comparison of injections of botulinum toxin and topical nitroglycerin ointment for the treatment of chronic anal fissure. N Engl J Med. 1999 Jul 8;341(2):65-9. Erratum in: N Engl J Med — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	macroscopic healing of the fissure		4 months	No
Secondary	complications		12 months	Yes
Secondary	fissure recurrence		12 months	No
Secondary	fissure related pain		12 months	No
Secondary	costs		12 months	No