Comparison of Treatment Success of Botox Injection in the Internal Sphincter Versus Isosorbidedinitrate Ointment in Patients With an Anal Fissure
Botulin Toxin Versus Isosorbidedinitrate Ointment in Treatment Anal Fissure; A Prospective, Blinded, Randomized Trial
1 other identifier
interventional
73
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2002
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 20, 2009
CompletedFirst Posted
Study publicly available on registry
January 23, 2009
CompletedJanuary 23, 2009
January 1, 2009
3.8 years
January 20, 2009
January 22, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
macroscopic healing of the fissure
4 months
Secondary Outcomes (4)
complications
12 months
fissure recurrence
12 months
fissure related pain
12 months
costs
12 months
Study Arms (2)
Botox injection
EXPERIMENTALinjection 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
ISDN ointment
ACTIVE COMPARATORapplication of ISDN 1% ointment 6 times a day. injection of placebo into internal anal sphincter
Interventions
injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline.
Injection of placebo into internal anal sphincter (ISDN ointment arm) Applied to the anoderm six times a day (Botox injection arm)
Eligibility Criteria
You may qualify if:
- all consecutive patients over the age of 18 with a chronic anal fissure presenting to our surgical outpatient clinic
You may not qualify if:
- pregnancy
- previous anal surgery
- Crohn's disease
- systemic causes of an anal fissure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1090 HM, Netherlands
Related Publications (1)
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.
PMID: 10395629RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Gerhards, MD
Onze Lieve Vrouwe Gasthuis
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 20, 2009
First Posted
January 23, 2009
Study Start
June 1, 2002
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
January 23, 2009
Record last verified: 2009-01