Chronic anal fissure
Conditions
Interventions
Trade Name: BOTOX
Pharmaceutical Form:
INN or Proposed INN: Botulinum Toxin Type A
CAS Number: 93384-43-1
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration unit: U unit(s)
Concentration ty
Sponsors
Hospital Universitario de Burgos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients of legal age who sign the informed consent form and are diagnosed with chronic anal fissure will be included in the study. Chronic anal fissure will be considered as that which has been evolving for more than 6 weeks, in spite of various hygienic-dietary treatments and/or relaxants (NTG) or calcium blockers and which macroscopically presents some of the aspects of chronicity referred to: indurated edges, observation in the fundus of internal anal sphincter fibers and/or sentinel polyp persisting for more than 6 weeks. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients in whom botulinum toxin injection is contraindicated are excluded from the study: patients with alterations of neuromuscular transmission such as myasthenia gravis, Lambert Eaton myasthenic syndrome, inflammatory bowel disease, concomitant treatment with aminoglycosides, pregnancy or lactation, asthma or adverse reactions to treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether the technique of ultrasound-guided botulinum toxin infiltration is more effective and safer than the standard one, by controlling the infiltration sites. The aim is to analyze whether the location of the botulinum toxin infiltration is an important factor in the result of the treatment. On the other hand, the aim is to standardize a technique and make it much more precise for the localization of the infiltration, through the use of the endorectal ultrasound probe. Therefore, our objective is to establish a novel technique that complements the standard technique, is reproducible and does not increase the risks and is even safer, as it controls the site of toxin infiltration.;Secondary Objective: Not applicable;Primary end point(s): The main variables that we will specify in the study will be whether there is healing of the fissure (epithelialization of the fissure and disappearance of symptoms such as pain or bleeding), that there is no recurrence and, finally, to assess the complications of treatment (mainly anal incontinence), especially anal incontinence.;Timepoint(s) of evaluation of this end point: 2, 8 and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Spain
Contacts
Public ContactMiriam Saiz
Unidad de Investigación, Hospital Universitario de Burgos
Outcome results
None listed