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

Primary Purpose

Anal Fissure

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Botox
ISDN ointment
Placebo
Sponsored by
Onze Lieve Vrouwe Gasthuis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Fissure focused on measuring anal fissure, fissura ani, botox, ISDN, Nitric oxide donor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Onze Lieve Vrouwe Gasthuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Botox injection

ISDN ointment

Arm Description

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

application of ISDN 1% ointment 6 times a day. injection of placebo into internal anal sphincter

Outcomes

Primary Outcome Measures

macroscopic healing of the fissure

Secondary Outcome Measures

complications
fissure recurrence
fissure related pain
costs

Full Information

First Posted
January 20, 2009
Last Updated
January 22, 2009
Sponsor
Onze Lieve Vrouwe Gasthuis
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1. Study Identification

Unique Protocol Identification Number
NCT00827736
Brief Title
Comparison of Treatment Success of Botox Injection in the Internal Sphincter Versus Isosorbidedinitrate Ointment in Patients With an Anal Fissure
Official Title
Botulin Toxin Versus Isosorbidedinitrate Ointment in Treatment Anal Fissure; A Prospective, Blinded, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Onze Lieve Vrouwe Gasthuis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fissure
Keywords
anal fissure, fissura ani, botox, ISDN, Nitric oxide donor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botox injection
Arm Type
Experimental
Arm Description
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
Arm Title
ISDN ointment
Arm Type
Active Comparator
Arm Description
application of ISDN 1% ointment 6 times a day. injection of placebo into internal anal sphincter
Intervention Type
Procedure
Intervention Name(s)
Botox
Intervention Description
injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline.
Intervention Type
Drug
Intervention Name(s)
ISDN ointment
Intervention Description
application of ISDN 1% ointment 6 times a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Injection of placebo into internal anal sphincter (ISDN ointment arm) Applied to the anoderm six times a day (Botox injection arm)
Primary Outcome Measure Information:
Title
macroscopic healing of the fissure
Time Frame
4 months
Secondary Outcome Measure Information:
Title
complications
Time Frame
12 months
Title
fissure recurrence
Time Frame
12 months
Title
fissure related pain
Time Frame
12 months
Title
costs
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Gerhards, MD
Organizational Affiliation
Onze Lieve Vrouwe Gasthuis
Official's Role
Study Director
Facility Information:
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
State/Province
Noord Holland
ZIP/Postal Code
1090 HM
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
10395629
Citation
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. doi: 10.1056/NEJM199907083410201. Erratum In: N Engl J Med 1999 Aug 19;341(8):624.
Results Reference
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Learn more about this trial

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

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