National Study on the Quality of Life of Patients With Anorectal Malformation
NCT ID: NCT02029248
Last Updated: 2017-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
762 participants
OBSERVATIONAL
2012-04-30
2015-04-30
Brief Summary
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Despite the better knowledge of the anatomy and physiology and the improvement of surgical management after birth, fecal and urinary incontinence can occur, due mainly to deficient nerve supply.
The quality of life of such patients is largely unknown in this country. The aim of the investigators study is to propose specific and generic questionnaires to the patients registered in the national database, correlated to their anatomical and functional status. A better understanding of such correlations should allow improvements in their medical and social management.
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Detailed Description
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The assessment of quality of life requires a self-report questionnaire composed of items related to physical, emotional and social functioning, and disease-related symptoms. A specific ARM questionnaire, the HAQL, was developed by a Dutch team and published in 2001. Associated with generic questionnaire, it allowed quality of life assessment in Dutch population.
The quality of life of such patients is largely unknown in this larger country. The aim of the investigators study is to propose specific (HAQL translated from Dutch to French) and generic questionnaires to the patients registered in the national database, correlated to their anatomical and functional status.
A better understanding of such correlations should allow improvements in their medical and social management.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Children 6-7
Patients who are between 6 and 7 years old
Quality of life questionnaire
Children 8-11
Patients who are between 8 and 11 years old
Quality of life questionnaire
Children 12-16
Patients who are between 12 and 16 years old
Quality of life questionnaire
Patients 17-30
Patients who are between 17 and 30 years old
Quality of life questionnaire
Interventions
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Quality of life questionnaire
Eligibility Criteria
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Inclusion Criteria
* Patients initially treated in a french pediatric surgery service for anorectal malformation
Exclusion Criteria
* Patients with concomitant malformations that can modify sphincter functions besides anorectal malformation (spina bifida, )
* Patients whose brain functions do not allow to reply to a questionnaire (mental retardation)
6 Years
30 Years
ALL
No
Sponsors
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MAREP ( Center For Rare Diseases Center Ano-Rectal And Pelvic Abnormalities)
OTHER
Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Guillaume Podevin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHU d'Angers (France)
Locations
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CHU Amiens
Amiens, , France
CHU Angers
Angers, , France
CHU Besançon
Besançon, , France
CHU Bordeaux
Bordeaux, , France
CHU Brest
Brest, , France
Hospices Civils de Lyon
Bron, , France
CHU Caen
Caen, , France
CHU Clermont-Ferrand
Clermont-Ferrand, , France
Hôpitaux Civils de Colmar
Colmar, , France
CHU Dijon
Dijon, , France
CHU Fort-de-France
Fort-de-France (Martinique), , France
CHU Grenoble
Grenoble, , France
AP-HP Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
CH Le Mans
Le Mans, , France
CHRU Lille
Lille, , France
CHU Limoges
Limoges, , France
AP-HM La Timone
Marseille, , France
AP-HM Hôpital Nord
Marseille, , France
CHU Montpellier
Montpellier, , France
CHU de Nantes
Nantes, , France
CHU Nice
Nice, , France
CHR Orléans
Orléans, , France
AP-HP Hôpital Trousseau
Paris, , France
AP-HP Hôpital Necker
Paris, , France
AP-HP Hôpital Robert Debré
Paris, , France
CHU Pointe-à-Pitre
Pointe-à-Pitre (Guadeloupe), , France
CHU Poitiers
Poitiers, , France
CHU Reims
Reims, , France
CHU Rennes
Rennes, , France
CHU Rouen
Rouen, , France
CHR La Réunion
Saint Denis (La Réunion), , France
CH Saint Brieuc
Saint-Brieuc, , France
CHU Saint Etienne
Saint-Etienne, , France
CHRU Strasbourg
Strasbourg, , France
CHU Toulouse
Toulouse, , France
CHRU Tours
Tours, , France
CHU Nancy
Vandœuvre-lès-Nancy, , France
Countries
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References
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Clermidi P, Podevin G, Cretolle C, Sarnacki S, Hardouin JB. The challenge of measuring quality of life in children with Hirschsprung's disease or anorectal malformation. J Pediatr Surg. 2013 Oct;48(10):2118-27. doi: 10.1016/j.jpedsurg.2013.03.071.
Mantoo S, Meurette G, Wyart V, Hardouin J, Cretolle C, Capito C, Sarnacki S, Podevin G, Lehur PA. The impact of anorectal malformations on anorectal function and social integration in adulthood: report from a national database. Colorectal Dis. 2013 Jun;15(6):e330-5. doi: 10.1111/codi.12186.
Podevin G, Petit T, Mure PY, Gelas T, Demarche M, Allal H, Becmeur F, Varlet F, Philippe P, Weil D, Heloury Y. Minimally invasive surgery for anorectal malformation in boys: a multicenter study. J Laparoendosc Adv Surg Tech A. 2009 Apr;19 Suppl 1:S233-5. doi: 10.1089/lap.2008.0137.supp.
Fleury J, Picherot G, Cretolle C, Podevin G, David A, Caillon J, Roze JC, Gras-le Guen C. Currarino syndrome as an etiology of a neonatal Escherichia coli meningitis. J Perinatol. 2007 Sep;27(9):589-91. doi: 10.1038/sj.jp.7211783.
Other Identifiers
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BRD/10/06-R
Identifier Type: -
Identifier Source: org_study_id
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