|- candidate number||2651|
|- NTR Number||NTR1012|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-jul-2007|
|- Secondary IDs||C-04.11 |
|- Public Title||A prospective randomised controlled trial in the treatment of anal fissures; Botulin-A Toxin versus Topical Diltiazem: BOTTOM-trial.|
|- Scientific Title||A prospective randomised controlled trial in the treatment of anal fissures; Botulin-A Toxin versus Topical Diltiazem: BOTTOM-trial.|
|- hypothesis||Botulin-A gives a better healingrate as Topical Diltiazem.|
|- Healt Condition(s) or Problem(s) studied||Anal fissure|
|- Inclusion criteria||Chronic anal fissure, without previous therapy.|
|- Exclusion criteria||1. Allergy to botuline A toxine and Diltiazem;|
2. Cardiovascular disease:
a. sever hypotension;
c. heart failure;
d. cardiogenic shock;
e. sever aortastenosis;
f. second or third degree AV-block;
g. “sick sinus” syndroom;
i. atrialfibrillation or flutter;
3. Myocardial infraction;
4. Neuromusculair dysfunction: myasthenia gravis or myasthenie (Eaton-Lambert syndrome), ALS.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2005|
|- planned closingdate||1-jun-2008|
|- Target number of participants||164|
|- Interventions||Botuline A injection (once) -Topical Diltiazem application (3-6 months).|
|- Primary outcome||Healing of fissure.|
|- Secondary outcome||Costs and adverse events.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| B.A. Twigt|
|- CONTACT for SCIENTIFIC QUERIES|| B.A. Twigt|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|Allergan, SLA Pharma|
|- Brief summary||Summary Bottom-trial;|
This study involves anal fissures. An elevated anal resting pressure can cause an anal fissure. Pain at defaecation will subsequent further elevate anal sfincter pressure. Increased pressure, in its turn, leads to a decrease in local blood flow causing local ischemia. Thus a vicious cirkel is created and chemical or surgical intervention is needed to perform a sfincterotomy in order to decrease anal resting pressure.
Medical treatment of chronic anal fissure (chemical sphincterotomy) has been introduced as a consequence of the morbidity attributed to surgical sphincterotomy. Surgical sphincterotomy has a complication rate of 25% regarding fecal incontinence en soiling Especially in women who gave labour.
An alternative to operation is medical treatment with an ointment of isosorbide dinitrate vaseline crème (ISDN), a topical NO-donor. However this, widely used, product is not officially registrered. Research addressing efficacy and safety is marginal. And in addition, ISDN causes in 84% of patients headaches, resulting in therapy faillure.
Two relatively new medicins, Botulinum toxin A and topical diltiazem, with healing rates between 67 and 87 percent will be compared. Both workingmechanism are based on relaxation of the internal sfincter. Botulinum toxin A and topical diltiazem are proven effective and safe in chronic anal fissures.
This trial is called: A prospective randomised controlled trial in the treatment of anal fissures Botulin-A Toxin versus Topical Diltiazem: Bottom-trial.
It is a double blinded RCT in which patients will get an injection in the anal sfincter and undergo a treatment of 3 months with a topical ointment. One half of the study population gets a Botulin-A Toxin injection and a placebo ointment. The other half gets a placebo injection and diltiazem ointment. After the study period the treatment will be revealed to the patient and the doctor.
Each patient without chronic cardial complaints or muscle weakness can participate. An anal fissure is easy to recognise and most of the time situated a twelve o'clock in knee-elbow position. Pain at or immediately after defaecation is pathognomonic. Participating in this study will not impend any other treatments or controls for patients.
|- Main changes (audit trail)|
|- RECORD||2-jul-2007 - 28-apr-2008|