No registrations found.
ID
Source
Brief title
Health condition
Fissura ani, 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;
4. costs.
Study objective
Treatment with Botox will give a better healing rate for anal fissures compared to treatment with isosorbidedinitrate ointment.
Study design
1, 2, 4, 6 and 12 months.
Intervention
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 injection of placebo in internal anal sphincter.
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 | NL1543 |
| NTR-old | NTR1614 |
| Other | : 31011972 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |