Clinical Trial: National Study on the Quality of Life of Patients With Anorectal Malformation
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: National Study on the Quality of Life of Patients With Anorectal Malformation (MARQOL)
Brief 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.
Detailed Summary:
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.
Sponsor: Nantes University Hospital
Current Primary Outcome: 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 [ Time Frame: At the time of the inclusion ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Kind of malformation, associated malformation, sequelas, handicap degree, social integration [ Time Frame: At the time of the inclusion ]
Original Secondary Outcome: Same as current
Information By: Nantes University Hospital
Dates:
Date Received: December 2, 2013
Date Started: April 2012
Date Completion:
Last Updated: July 20, 2015
Last Verified: July 2015
