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

Information source: Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anal Fissure

Intervention: Botox (Procedure); ISDN ointment (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Onze Lieve Vrouwe Gasthuis

Official(s) and/or principal investigator(s):
Michael Gerhards, MD, Study Director, Affiliation: Onze Lieve Vrouwe Gasthuis

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.

Clinical Details

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

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

Primary outcome: macroscopic healing of the fissure

Secondary outcome:

complications

fissure recurrence

fissure related pain

costs

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Onze Lieve Vrouwe Gasthuis, Amsterdam, Noord Holland 1090 HM, Netherlands
Additional Information

Starting date: June 2002
Last updated: January 22, 2009

Page last updated: August 23, 2015

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