Comparison of Botox versus Isosorbidedinitrate Ointment in the treatment of an anal fissure.

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-OMON27249

Enrollment

Registered

2009-01-13

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

Anal fissure

Interventions

Treatment in group I consisted of injection of 10U of BT (Botox®

Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline16. In addition, they were given a placebo ointment to apply to the anoderm six times a day Patients in group II recei

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 and 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)