Dettagli per singolo studio

DEC-NET Serial number IT503

Published online	07/10/2005 14.58.00
Last updated	10/11/2005 11.39.07

Other protocol ID number
Current trial status	Planned (i.e. not yet recruiting participants)
Major Disease (ICD9 class)	FUNCT DIS INTESTINE NEC
Experimental drug
Tossina Botulinica di tipo A Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	1-18 years
Eligibility criteria
Inclusion criteria
Patients with: - Hirschsprung disease that have been operated on, but with residual achalasia of the internal anal sphincter - neurogenic achalasia of the internal anal sphincter - type B intestinal neuronal dysplasia without anal inhibitory reflex Adults who were treated for Hirschsprung disease as children will also be included
Exclusion criteria

Trial design/methodology
Phase	3
Kind of study	Efficacy Safety
Design
Purpose of study
To provide an alternativa therapeutic option to sphyncteromyotomy, which is destructive and irreversible, in patients with international sphincter achalasia that does not respond to pharmacological treatment (laxatives or diet). To temporarily resolve symptoms (constipation or persistent). To temporarily resolve internal anal sphincter achalasia in patients with Hirschsprung that have been operated on, but in whom symptoms persost.




Summary of study design, objectives, and ongoing research findings
Study on the efficacy of inoculation with type A botulinum toxin in the internal anal and sphincter in the temporary or permanent treatment of achalasia (spasm) and, therefore, also of occlusive symptoms (constipation, enterocolitis) in patients with Hirschsprung Disease that have been operated on, but in whom symptoms persist, and in those with neurogenic internal anal sphincter alchalasia and intestinal neuronal dysplasia.