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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00827736
First Posted: January 23, 2009
Last Update Posted: January 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Onze Lieve Vrouwe Gasthuis
  Purpose
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.

Condition Intervention Phase
Anal Fissure Procedure: Botox Drug: ISDN ointment Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Botulin Toxin Versus Isosorbidedinitrate Ointment in Treatment Anal Fissure; A Prospective, Blinded, Randomized Trial

Resource links provided by NLM:


Further study details as provided by Onze Lieve Vrouwe Gasthuis:

Primary Outcome Measures:
  • macroscopic healing of the fissure [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • complications [ Time Frame: 12 months ]
  • fissure recurrence [ Time Frame: 12 months ]
  • fissure related pain [ Time Frame: 12 months ]
  • costs [ Time Frame: 12 months ]

Enrollment: 73
Study Start Date: June 2002
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botox injection
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
Procedure: Botox
injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline.
Active Comparator: ISDN ointment
application of ISDN 1% ointment 6 times a day. injection of placebo into internal anal sphincter
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
Drug: Placebo

Injection of placebo into internal anal sphincter (ISDN ointment arm)

Applied to the anoderm six times a day (Botox injection arm)


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00827736


Locations
Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Noord Holland, Netherlands, 1090 HM
Sponsors and Collaborators
Onze Lieve Vrouwe Gasthuis
Investigators
Study Director: Michael Gerhards, MD Onze Lieve Vrouwe Gasthuis
  More Information

Publications:
Responsible Party: S.Festen, MD, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier: NCT00827736     History of Changes
Other Study ID Numbers: 00.058
First Submitted: January 20, 2009
First Posted: January 23, 2009
Last Update Posted: January 23, 2009
Last Verified: January 2009

Keywords provided by Onze Lieve Vrouwe Gasthuis:
anal fissure
fissura ani
botox
ISDN
Nitric oxide donor

Additional relevant MeSH terms:
Fissure in Ano
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents