E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic anal fissure |
Fisura anal crónica |
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E.1.1.1 | Medical condition in easily understood language |
Chronic anal fissure |
Fisura anal crónica |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Assess the cure rate of chronic anal fissure with botulinum toxin in 2 years of follow-up |
Valorar la tasa de curación de la fisura anal crónica con toxina botulínica en un seguimiento de 2 años |
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E.2.2 | Secondary objectives of the trial |
* 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. |
*Determinar el efecto de la toxina botulínica A (incobotulinumtoxinA) en la relajación del esfínter anal interno en pacientes con fisura anal crónica. *Valorar el control del dolor con toxina botulínica. *Determinar qué tipo de complicaciones pueden aparecer con el tratamiento con toxina botulínica y estimar su proporción. *Establecer los factores pronósticos en el fracaso del tratamiento de la fisura anal crónica con toxina botulínica. *Calcular los perfiles de riesgo para la aparición de complicaciones. *Estimar el tiempo mediano en la aparición del fracaso. *Conocer el porcentaje de pacientes en los que se podría evitar un tratamiento quirúrgico, mediante el uso de esta terapia. *Valorar calidad de vida antes y después del uso de la toxina. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
*Pacientes que acudan a la Consulta de Cirugía con diagnóstico de fisura anal crónica. * Pacientes mayores de 18 años de edad con clínica de fisura de más de dos meses de evolución que no han respondido a tratamientos médicos de fisura anal previos. El tratamiento médico consistiría en medidas higiénico dietéticas y tratamiento analgésico sistémico y local con pomadas (Anexo 1). Estas pomadas serán bien calcio antagonistas (Diltiazem 2%) o nitratos (Rectogesic 0.4%), ambas con función relajante del músculo liso del ano por distintas vías de actuación. Este tratamiento debe prescribirse durante 6-8 semanas antes de valorar si se ha producido o no curación o mejoría. |
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E.4 | Principal 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. |
*Menores de edad. *Pacientes con diagnóstico de fisura anal crónica que no sea idiopática. *Pacientes que no hayan recibido previamente tratamiento médico para la fisura anal. *Pacientes con contraindicación para el uso de la Toxina botulínica tipo A: Miastenia gravis, síndrome Eaton-Lambert, embarazadas, déficit de acelticolina. |
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E.5 End points |
E.5.1 | 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. |
Se definirá curación, cuando la fisura esté cicatrizada y sin clínica; mejoría, cuando la fisura persista en ausencia de síntomas; y fracaso cuando persistan la fisura y los síntomas. En este último grupo, se incluirá a los pacientes que por su sintomatología requirieron manejo quirúrgico. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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. |
Eficacia: Se evaluarán a la semana el dolor mediante la escala EVA, escape de gases y heces y la exploración física objetivando si hay desaparición de la lesión, así como también al mes y tres meses donde se incluirá además la realización de manometría control y ecografía. Se efectuará seguimiento a los pacientes en la Consulta de Cirugía durante dos años para comprobar recurrencia o no del proceso. Se definirá como fracaso al tratamiento la recidiva de la fisura anal crónica tras el periodo de seguimiento. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Estudio de tipo prospectivo de cohorte única |
Prospective study of a single cohort |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
ultima visita ultimo paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |