National Study on the Quality of Life of Patients With Anorectal Malformation
- Conditions
- Anorectal Malformation
- Interventions
- Other: Quality of life questionnaire
- Registration Number
- NCT02029248
- Lead Sponsor
- Nantes University Hospital
- 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 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 762
- Patients who are between 6 and 30 years old
- Patients initially treated in a french pediatric surgery service for anorectal malformation
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Children 6-7 Quality of life questionnaire Patients who are between 6 and 7 years old Patients 17-30 Quality of life questionnaire Patients who are between 17 and 30 years old Children 8-11 Quality of life questionnaire Patients who are between 8 and 11 years old Children 12-16 Quality of life questionnaire Patients who are between 12 and 16 years old
- Primary Outcome Measures
Name Time Method 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 At the time of the inclusion 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.
- Secondary Outcome Measures
Name Time Method Kind of malformation, associated malformation, sequelas, handicap degree, social integration At the time of the inclusion Clinical questionnaire
Trial Locations
- Locations (37)
CHU Rennes
🇫🇷Rennes, France
CH Saint Brieuc
🇫🇷Saint Brieuc, France
CHU Reims
🇫🇷Reims, France
AP-HP Hôpital Necker
🇫🇷Paris, France
CHRU Tours
🇫🇷Tours, France
CHU Amiens
🇫🇷Amiens, France
CHU Nancy
🇫🇷Vandoeuvre-les-Nancy, France
AP-HP Hôpital Trousseau
🇫🇷Paris, France
CHU Poitiers
🇫🇷Poitiers, France
CHU Pointe-Ã -Pitre
🇫🇷Pointe-à -Pitre (Guadeloupe), France
CHR La Réunion
🇫🇷Saint Denis (La Réunion), France
CHU Saint Etienne
🇫🇷Saint Etienne, France
AP-HP Hôpital Robert Debré
🇫🇷Paris, France
CHU Rouen
🇫🇷Rouen, France
CHU Nice
🇫🇷Nice, France
CHR Orléans
🇫🇷Orléans, France
CHU Montpellier
🇫🇷Montpellier, France
CHU de Nantes
🇫🇷Nantes, France
CHRU Strasbourg
🇫🇷Strasbourg, France
CHU Toulouse
🇫🇷Toulouse, France
CHU Angers
🇫🇷Angers, France
CHU Besançon
🇫🇷Besançon, France
CHU Bordeaux
🇫🇷Bordeaux, France
Hospices Civils de Lyon
🇫🇷Bron, France
CHU Brest
🇫🇷Brest, 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
CH Le Mans
🇫🇷Le Mans, France
AP-HP Hôpital Bicêtre
🇫🇷Kremlin-Bicêtre, France
CHRU Lille
🇫🇷Lille, France
CHU Limoges
🇫🇷Limoges, France
AP-HM Hôpital Nord
🇫🇷Marseille, France
AP-HM La Timone
🇫🇷Marseille, France