RecruitingNCT05450991

Long-term Qualitative and Quantitative Outcomes of Children With Hirschsprung's Disease and Anorectal Malformations


Sponsor

Alder Hey Children's NHS Foundation Trust

Enrollment

1,200 participants

Start Date

Jan 25, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

Approximately 340 babies are born with Hirschsprung's disease (HSCR) or an anorectal malformation (ARM) per year in the UK. Most require corrective surgery in the newborn or early infancy period. In both conditions, there is both variability in the severity of the condition and the type of operative technique used. Many children do well following surgery and have good continence in later life. However a significant proportion of children suffer from a lifetime of constipation or incontinence. This has a significant impact on their social and psychological welfare and is a significant burden on healthcare resources. Due to the variation in practice, there are limited data on long-term outcomes following surgery for children with HSCR or ARMs. Where studies have been performed, they often include small numbers, non-standardised outcome measures and short follow-up periods. It is therefore difficult to ascertain the effectiveness of different management strategies. However, a recent Delphi process has been carried out to establish 10 core measures in HSCR to improve outcome reporting. This research group has a long track record in this research area, specifically in the determination of long-term outcomes of children with HSCR, leading to well cited papers within the literature. In the last 2 decades there has been a significant change in the surgical techniques used in HSCR, however the underlying evidence base for this is still lacking. This study seeks to follow-on from previous studies looking specifically at the long-term outcomes in children with HSCR. Furthermore, the aim is to widen the study to encompass all children treated at Alder Hey and also to use the same methodology to assess long-term outcomes for children with ARMs, as both groups of patients experience similar long term morbidity. This will provide qualitative and quantitative data aiding counselling parents of children with HSCR/ARM.


Eligibility

Inclusion Criteria2

  • 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 Criteria4

  • 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

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Interventions

PROCEDUREPull through

Children diagnosed with Hirschpsrung's Disease or an anorectal malformation, with or without operative intervention will be included


Locations(1)

Alder Hey Children's Hospital

Liverpool, Merseyside, United Kingdom

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NCT05450991


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