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

NCT00827736 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2009-01-23

No results posted yet for this study

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.

Conditions

  • Anal Fissure

Interventions

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)

Sponsors & Collaborators

  • Onze Lieve Vrouwe Gasthuis

    lead OTHER

Principal Investigators

  • Michael Gerhards, MD · Onze Lieve Vrouwe Gasthuis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2006-03-31
Completion
2006-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00827736 on ClinicalTrials.gov