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:
Information provided by:
Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier:
NCT00827736
First received: January 20, 2009
Last updated: January 22, 2009
Last verified: January 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • fissure recurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • fissure related pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 20, 2009
Last Updated: January 22, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Botulinum Toxins, Type A
Nitric Oxide Donors
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014