Long-term outcomes for children with Hirschsprung's disease and anorectal malformations
Long-term Qualitative and Quantitative Outcomes of Children With Hirschsprung's Disease and Anorectal Malformations
This study looks at how well children with Hirschsprung's disease and anorectal malformations are doing in the long run after their surgeries to help families understand their health and quality of life better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Sex | All |
| Sponsor | Alder Hey Children's NHS Foundation Trust Academic / other |
| Locations | 1 site (Liverpool, Merseyside) |
| Trial ID | NCT05450991 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term qualitative and quantitative outcomes of children diagnosed with Hirschsprung's disease and anorectal malformations. It will involve approximately 340 children who have undergone surgical treatment since 1991, focusing on the variability in surgical techniques and their impact on health outcomes. The study seeks to address the lack of comprehensive data on the effectiveness of different management strategies and the long-term quality of life for these patients. By collecting standardized outcome measures, the research aims to provide clearer prognostic information for families.
Who should consider this trial
Good fit: Ideal candidates include children diagnosed with Hirschsprung's disease or anorectal malformations who have been treated at Alder Hey Children's Hospital since 1991.
Not a fit: Patients with non-histologically diagnosed Hirschsprung's disease or those whose treatment has primarily occurred outside the participating centers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of long-term outcomes and better management strategies for children with these conditions.
How similar studies have performed: While there have been studies on these conditions, this research aims to fill a gap in long-term outcome data, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All children treated at either center with histologically confirmed Hirschsprung's Disease since diagnosis from 1991 * All children diagnosed with anorectal malformation on the basis of position in relation to the external sphincter and size Exclusion Criteria: * Patients with non-histologically diagnosed Hirschsprung's Disease * Patients whose initial primary treatment or majority of follow-up for either condition has been external to either center * Patients with funnel anus * Adults who are unable to consent for themselves
Where this trial is running
Liverpool, Merseyside
- Alder Hey Children's Hospital — Liverpool, Merseyside, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.