|- candidate number||5154|
|- NTR Number||NTR1628|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-jan-2009|
|- Secondary IDs||00.058 |
|- Public Title||Comparison of Botox versus Isosorbidedinitrate Ointment in the treatment of an anal fissure.|
|- Scientific Title||Botulin Toxin versus Isosorbidedinitrate Ointment in Treatment Anal Fissure;
A Prospective, Blinded, Randomized Trial.
|- hypothesis||Botulin toxin will show a better healing rate after 4 months of treatment than Isosorbidedinitrate Ointment (90% vs 65%).|
|- Healt Condition(s) or Problem(s) studied||Anal fissure|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2002|
|- planned closingdate||1-mrt-2006|
|- Target number of participants||86|
|- 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 received a placebo injection and ISDN 1% ointment.|
|- 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.
|- Timepoints||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.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| S. Festen|
|- CONTACT for SCIENTIFIC QUERIES|| S. Festen|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|- Brief 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.
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.
|- Main changes (audit trail)|
|- RECORD||13-jan-2009 - 9-sep-2009|