No registrations found.
ID
Source
Brief title
Health condition
Anal fissure
Sponsors and support
Intervention
Outcome measures
Primary outcome
Macroscopic healing of the fissure at 4 months.
Secondary outcome
1. Fissure related pain;
2. Treatment induced complications;
3. Fissure recurrence and costs.
Background summary
Background:
Nitric oxide donors like Isosorbide Dinitrate (ISDN) are still considered the first choice of treatment for anal fissures. After a number of reports on the successful treatment of anal fissures with Botulin toxin (BT), this randomized blinded trial was conducted to compare BT with ISDN in the treatment of chronic anal fissures.
Methods:
Patients were randomized into two groups. Group I patients received an injection of BT in the internal anal sphincter (IAS) and a placebo ointment, whereas group II patients received a placebo injection and ISDN ointment. The primary endpoint was macroscopic healing of the fissure after 4 months.
Study objective
Botulin toxin will show a better healing rate after 4 months of treatment than Isosorbidedinitrate Ointment (90% vs 65%).
Study design
Evaluation of complaints related to the anal fissure was done before treatment and during follow up at 1, 2, 4, 6 and 12 months post treatment using a questionnaire.
Intervention
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 received a placebo injection and ISDN 1% ointment.
S. Festen
Amsterdam
The Netherlands
+31 (0) 20 5999111
s.festen@olvg.nl
S. Festen
Amsterdam
The Netherlands
+31 (0) 20 5999111
s.festen@olvg.nl
Inclusion criteria
All consecutive patients over the age of 18 with a chronic anal fissure presenting to our surgical outpatient clinic.
Exclusion criteria
1. Pregnancy;
2. Previous anal surgery;
3. Crohn’s disease;
4. Systemic causes of an anal fissure.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL690 |
| NTR-old | NTR1628 |
| Other | : 00.058 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |