|- candidate number||0|
|- NTR Number||NTR36|
|- Date ISRCTN created||5-aug-2005|
|- date ISRCTN requested||18-jul-2005|
|- Date Registered NTR||21-jun-2005|
|- Secondary IDs||N/A |
|- Public Title||The effect of additional use of enemas versus the standard treatment of chronic constipation in children.|
|- Scientific Title||The effect of additional use of enemas versus the standard treatment of chronic constipation in children.|
|- hypothesis||1. Early intervention with oral AND rectal laxatives will lead to a higher success percentage compared to standard treatment in constipated children;|
2. Long lasting fecal stasis leads to abnormal rectal functions (compliance and sensation);
3. Early frequent rectal laxatives prevent irreversible damage to rectal function.
|- Healt Condition(s) or Problem(s) studied||Constipation|
|- Inclusion criteria||Rome II-criteria for constipation, age 8-18 year.|
|- Exclusion criteria||1. Hirschsprung's disease;|
2. gastro-intestinal surgery;
3. anorectal anomaly;
4. metabolism disorders;
5. mental retardation.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2003|
|- planned closingdate||1-dec-2005|
|- Target number of participants||100|
|- Interventions||Group 1: weekly enemas + standardtreatment;|
Groep 2: standardtreatment with oral laxantia (movicolon).
|- Primary outcome||Defecation frequency, soiling/encopresis frequency, stool consistency; use of laxatives.|
Patients will visit our out-patient visits for follow-up at several fixed moments: intake and t= 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks, 39 weeks and 52 weeks.
During this study, all patients will record in a specific diary on primary outcome measurements.
|- Secondary outcome||Rectal compliance and sensation at t=0 en t=52 weeks; A barostat is performed in all children pre-treatment and after 1 year of treatment and rectal functions are determined (rectal compliance and sensation). The results of t=0 and t= 52 weeks are compared to assess possible differences in rectal function.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. Marc A. Benninga|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. Marc A. Benninga|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Pediatric|
(Source(s) of Monetary or Material Support)
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||11-jul-2005 - 17-sep-2008|