Injection with Botox in the anal sphicnter versus treatment with isosorbidedinitrate ointment for patients with an anal fissure. what is the most successful treatment?

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22742

Enrollment

Registered

2009-01-08

Start date

2002-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fissura ani, anal fissure.

Interventions

group I: Injection of 2x 10u botulin toxin in internal anal sphincter and application of placebo ointment 6 times daily. group II: application of isosorbidedinitrate ointment 6 times daily and inject

Eligibility

Inclusion criteria

Inclusion criteria: All consecutive patients over the age of 18 with a chronic anal fissure presenting to our surgical outpatient clinic.

Exclusion criteria

Exclusion criteria: 1. Pregnancy; 2. previous anal surgery; 3. Crohn’s disease; 4. systemic causes of an anal fissure.

Design outcomes

Primary

Measure	Time frame
Macroscopic healing of the fissure at 4 months.	—

Secondary

Measure	Time frame
1. Fissure related pain; 2. treatment induced complications; 3. fissure recurrence; 4. costs.	—

Contacts

Public ContactS. Festen

Onze Lieve Vrouwe Gasthuis, Oosterpark 9

s.festen@olvg.nl+31 (0) 20 5999111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)