National Study on the Quality of Life of Patients With Anorectal Malformation

Anorectal Malformation Clinical Trial

— MARQOL  

Official title:

National Study on the Quality of Life of Patients With Anorectal Malformation (MARQOL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029248
• Other study ID #: BRD/10/06-R
• Status: Completed
• Phase: N/A
• First received: December 2, 2013
• Last updated: July 18, 2017
• Start date: April 2012
• Est. completion date: April 2015

Study information

• Verified date: July 2017
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Anorectal malformations, occurring approximately 1 in 5000 live births, mainly involve the distal anus and rectum, but also sometimes the urinary and genital tracts. Defects range from the minor and easily treated with an excellent functional prognosis, to those that are complex and often associated with a poor functional prognosis.

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.

Description:

Anorectal malformations (ARM), occurring approximately 1 in 5000 live births, mainly involve the distal anus and rectum, but also sometimes the urinary and genital tracts. Defects range from the minor and easily treated with an excellent functional prognosis, to those that are complex and often associated with a poor functional prognosis. 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. A few studies and clinical practice have shown that disease-specific problems of ARM have an effect on somatic function, mental health and psychosocial functioning.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 762
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 30 Years

Eligibility

Inclusion Criteria:

• Patients who are between 6 and 30 years old

• Patients initially treated in a french pediatric surgery service for anorectal malformation

Exclusion Criteria:

• Patients lost from sight or dead

• 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)

Related Conditions & MeSH terms

• Anorectal Malformation
• Congenital Abnormalities

Intervention

Other:
• Quality of life questionnaire

Locations

Country	Name	City	State
France	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	Kremlin-Bicêtre
France	CH Le Mans	Le Mans
France	CHRU Lille	Lille
France	CHU Limoges	Limoges
France	AP-HM Hôpital Nord	Marseille
France	AP-HM La Timone	Marseille
France	CHU Montpellier	Montpellier
France	CHU de Nantes	Nantes
France	CHU Nice	Nice
France	CHR Orléans	Orléans
France	AP-HP Hôpital Necker	Paris
France	AP-HP Hôpital Robert Debré	Paris
France	AP-HP Hôpital Trousseau	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	CH Saint Brieuc	Saint Brieuc
France	CHR La Réunion	Saint Denis (La Réunion)
France	CHU Saint Etienne	Saint Etienne
France	CHRU Strasbourg	Strasbourg
France	CHU Toulouse	Toulouse
France	CHRU Tours	Tours
France	CHU Nancy	Vandoeuvre-les-Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	MAREP (Centre maladies rares Malformations Ano-Rectales Et Pelviennes)

Country where clinical trial is conducted

France, 

References & Publications (4)

Clermidi P, Podevin G, Crétolle 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life measured by HAQL specific questionnaire and two generic questionnaires: VSPA for children or WHOQOL-BREF for adults; functional status measured by Krickenbeck score	HAQL: between 35 and 48 items (depending on the age of the patients) composing 8 dimensions; VSPA: 39 items composing 8 dimensions; WHOQOL-BREF: 26 items composing 4 dimensions; Krickenbeck: 3 items.	At the time of the inclusion
Secondary	Kind of malformation, associated malformation, sequelas, handicap degree, social integration	Clinical questionnaire	At the time of the inclusion