An interventional study of psychometric evaluation and neuropsychological evaluation in Hirschsprung's Disease (HD), sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 8 Years to 13 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Supportive care
Hirschsprung's disease (HD) is a rare congenital disease (1:5000) characterized by neonatal functional low bowel obstruction that is caused by aganglionosis of the distal bowel. HD treatment consists in surgery of colonic reduction in the early childhood, requiring afterward a long-term follow-up. In the long term complications (incontinence, constipation, enterocolitis, soiling)but also iterative anesthesia in childhood and repeated hospitalizations can have negative effects on child's development.
The main aim of the study is to estimate neuropsychological development at school age (6-10 years). Of children operated of HD Secondary aims are evaluation of the neuro-driving development and global health, comparison of quality of life levels to those of French population standards as well as to study the complex relations between on one hand the quality of life of these children and on the other hand the socio-demographic data, the initial clinical elements and the surgical coverage, as well as their health and current cognitive profile.
This multicenter study included pediatric surgery departments of Marseille. All children born between 1/1/2005 and 31/12/2010 and presenting HD represent the population. All the families will be contacted resting on the networks of set up follow-up. A written agreement will be collected with the parents. For all the participating children, a consultation will be organized: quality of life data (reported by children and by their parents in validated standardized questionnaires), clinical examination of the child, cognitive profile of the child. The duration of inclusion is scheduled for 12 months.
This is the first French study using auto-reported data on children's quality of life at school age affected by a HD. The results of this study will allow developing hypotheses on predictive risk factors for neuropsychological development disorders. Besides a better knowledge of the relation existing between these children quality of life and their functional results due to the disease could help clinicians in their medical reflections.
63 studies on the registry are indexed under Hirschsprung Disease; 24 are open to participants now.
This study's enrollment of 2 is below the median of 50 across 32 interventional studies indexed under Hirschsprung Disease.
Browse Hirschsprung Disease studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neuropsychological assessment at elementary school
Behavioral: psychometric evaluation · Behavioral: neuropsychological evaluation
Wechsler type composite scales (WISC)
Evaluation of child behavior by the Goodman questionnaire: Strengths and Difficulties Questionnaire
Evaluation of a sensory deficit
Administration d'un test psychometric de type Wechsler. The Wechsler Intelligence Scale for Children (WISC). The WISC-IV includes 15 subtests exploring four major components assessing the different intellectual skills essential to learning processes. The minimum score is 70, the normality between 90 ant 110, the maximum score is 130.
Time frame: 12 months
Evaluation of child behavior by the Goodman questionnaire: Strengths and Difficulties Questionnaire (SDQ).
It includes 25 questions that are asked to parents. It is used within research, evaluating treatment outcome and as part of clinical assessment in order to examine a child's mental well-being. A total difficulties score is calculated using the SDQ, which ranges from 0-40. Each 1 point increase in the total difficulties score corresponds with an increase in the risk of developing a mental health disorder. Categories have been proposed by Youth in Mind authors in order to assess whether a child's score is close to average, slightly above average, high or very high.
Time frame: 12 months
Plan to share: No
Ran from Jan 2018 to primary completion in Jan 2019, 12 months.
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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