Skip to main content
OpenTrials
Completed

NCT Number: NCT00827736

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anal Fissure Anus Diseases Digestive System Diseases Fissure in Ano Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, 1090 HM, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botox

Procedure

injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline.

ISDN ointment

Drug

application of ISDN 1% ointment 6 times a day

Placebo

Drug

Injection of placebo into internal anal sphincter (ISDN ointment arm)

Applied to the anoderm six times a day (Botox injection arm)

Primary outcomes

  1. macroscopic healing of the fissure

    Time frame: 4 months

Secondary outcomes

  1. complications

    Time frame: 12 months

  2. fissure recurrence

    Time frame: 12 months

  3. fissure related pain

    Time frame: 12 months

  4. costs

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Onze Lieve Vrouwe Gasthuis

Other

Registry information

Official study title

Botulin Toxin Versus Isosorbidedinitrate Ointment in Treatment Anal Fissure; A Prospective, Blinded, Randomized Trial

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Jan 23, 2009
Registry last updated
Jan 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.