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

Nantes University Hospital (NUH)

Status

Completed

Conditions

Anorectal Malformation

Treatments

Other: Quality of life questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT02029248

BRD/10/06-R

Details and patient eligibility

About

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.

Full 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.

Enrollment

762 patients

Sex

All

Ages

6 to 30 years old

Volunteers

No Healthy Volunteers

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)