Dettagli per singolo studio

DEC-NET Serial number GB283

Published online	09/07/2004 12.30.00
Last updated	09/08/2005 10.16.55

Other protocol ID number	N0176104213
This trial has been approved by an ethics committee
Current trial status	Open (actively recruiting new participants)
First subject enrolment Target N. of subjects	10/2003 30
Major Disease (ICD9 class)	ANAL SPASM
Experimental drug
Botulinum Toxin Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	2-16
Eligibility criteria
Inclusion criteria
Children who have benign anal disease Inappropriate contraction of the anal sphincter
Exclusion criteria
parents and or children given informed consent
Trial design/methodology
Phase	4
Kind of study	Efficacy
Design
Purpose of study
To address specifically the use of botulinum toxin injections into the anal sphincter of children for the diseases in which there is inappropriate contraction of the internal anal sphincter.
Primary outcomes
Manometric and ultrasound findings; improvements in pain and constipation as recorded in the doctor's record. These would enable calculation of validated scores for constipation and pain. In the case of anal fissure and fistula, the degree of healing would also be recorded.


Summary of study design, objectives, and ongoing research findings
Inappropriate contraction ( and lack of appropriate relaxation) of the internal anal sphincter is seen in a number of disease in childhood-most notably Hirschsprung's disease, certain types of constipation, anal fissue, anal fistula and post-surgery. Failure to the anal sphincter to relax makes defaecation painful, and as a consequence children often become constipated exacerbating the problem. Botulinum toxin is used in aduls for these conditions. In children it has been used only for spasticity, in order to relax over-contracted muscle. This study will address specifically the use of botulinum toxin injections into the anal sphincter of chldren for the diseases in which there is inappropriate contraction of the internal anal sphincter. Outcome measure: Manometric and ultrasound findings. Improvements in pain and constipation as recorded in the doctor's record. These would enable calculation of validated scores for constipation and pain. In the case of anal fissure and fistula, the degree of healing would also be recorded.