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

Sponsored by:	Onze Lieve Vrouwe Gasthuis
Information provided by:	Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier:	NCT00827736

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Botulin Toxin Versus Isosorbidedinitrate Ointment in Treatment Anal Fissure; A Prospective, Blinded, Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Botox

U.S. FDA Resources

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
Botox injection: Experimental 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.
ISDN ointment: Active Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827736

Locations

Netherlands, Noord Holland
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:

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 1999 Aug 19;341(8):624.

Responsible Party:	Onze Lieve Vrouwe Gasthuis ( S.Festen, MD )
Study ID Numbers:	00.058
Study First Received:	January 20, 2009
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00827736 History of Changes
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

Study placed in the following topic categories:

Nitric Oxide
Fissure in Ano
Botulinum Toxins
Digestive System Diseases
Gastrointestinal Diseases

Peripheral Nervous System Agents
Botulinum Toxin Type A
Intestinal Diseases
Rectal Diseases
Nitric Oxide Donors

Additional relevant MeSH terms:

Fissure in Ano
Digestive System Diseases
Gastrointestinal Diseases
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents

Botulinum Toxin Type A
Intestinal Diseases
Rectal Diseases
Anus Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009