Chronic anal fissure
Conditions
Interventions
Trade Name: Xeomin®
Product Name: IncobotulinumtoxinA
Product Code: IncobotulinumtoxinA
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BOTULINUM TOXIN TYPE A
CAS Number: 9
Sponsors
Dra. A. Teresa Calderón Duque
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Patients seen in the clinical Surgery Consultation with diagnosis of chronic anal fissure. * Patients older than 18 years of age with a diagnostic of fissure of more than two months of evolution who have not responded to previous anal fissure medical treatments. Medical treatment would consist of hygienic dietary measures and systemic and local analgesic treatment with ointments (Annex 1). These ointments will be either calcium antagonists (Diltiazem 2%) or nitrates (Rectogesic 0.4%), whose main function is to relax the smooth muscle of the anus. This treatment should be prescribed for 6-8 weeks before assessing whether or not there has been healing or improvement Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: *Minors *Patients with diagnosis of chronic anal fissure that it isn’t idiopathic. * Patients who have not previously received medical treatment for the anal fissure. * Patients with contraindication to the use of Botulinum Toxin type A: Myasthenia gravis, Eaton-Lambert syndrome, pregnant women, acelticoline deficiency.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: We will evaluate the pain with EVA scale, exhaust gases and feces and physical examination to see if the lession has dissapeared. Also, we will do a control manometry and ecography at 1 and 3 months after the treatment. Patients will be followed up at the clinical surgery consultation for two years. Recurrence of chronic anal fissure after the follow-up period will be defined as treatment failure.;Timepoint(s) of evaluation of this end point: 2 years | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the cure rate of chronic anal fissure with botulinum toxin in 2 years of follow-up;Secondary Objective: * Determine the effect of botulinum toxin A (incobotulinumtoxinA) on the relaxation of the internal anal sphincter in patients with chronic anal fissure. * Assess pain control with botulinum toxin. * Determine what type of complications may appear with botulinum toxin treatment and estimate their proportion. * Establish prognostic factors in the failure of treatment of chronic anal fissure with botulinum toxin. * Calculate the risk profiles for the emergence of complications. * Estimate the median time in the emergence of failure. * Know the percentage of patients in whom a surgical treatment could be avoided, through the use of this therapy. * Assess quality of life before and after using the toxin.;Primary end point(s): Recovery will be defined, when the fissure is healed and without symptoms; Improvement, when the fissure endures without symptons; and failure when both fissure and symptoms endure. In the last group, patients who required surgical management, will be included.;Timepoint(s) of evaluation of this end point: 2 years | — |
Countries
Spain
Contacts
Public ContactDra. Pilar Cruz y Dra Laura Arriero
Hospital Nuestra Sra. del Prado
Outcome results
None listed