Anal Fissure
Conditions
Brief summary
To evaluate the effect on healing rates of two different prognostic factors in patients treated with Dysport® for anal fissure: duration of fissure and dose of study drug
Interventions
BIOLOGICALBotulinum toxin type A
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients having idiopathic anal fissure in the posterior anal midline * Patients having anal fissure present for less than 6 months * Patients having symptoms (pain) present for a minimum of 2 weeks and not responding after 2 weeks of standard therapy (diet, laxatives, sitz-bathes)
Exclusion criteria
* Patients having anal fistulas or anal fissure of various causes such as Crohn disease, Behcet infectious ulceration, anal suppuration, subfissural infiltration, abscesses, acute haemorrhoidal attacks or inflammatory bowel disease * Patients having idiopathic anal fissure in the anterior anal midline * Patients having lateral or multiple fissures * Patients having anal or perianal cancer * Patients who underwent previous anal surgery or have cicatricial alterations or post-surgical cicatricial lesions * Patients receiving drugs affecting neuromuscular transmission * Patients who have received topical anaesthetic within 3 days of injection * Patients receiving local treatment by myorelaxing agent * Patients receiving prohibited analgesics * Patients having bleeding disturbances or currently using coumarin derivates * Patients having myasthenia or any genetic muscle disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing of the anal fissure by complete re-epithelisation of the anal canal mucosa. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of anal pain measured by the patients on Analogue Visual Pain Scale. | — |
Countries
Czechia, Poland, Romania, Tunisia
Outcome results
None listed