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

This study is currently recruiting participants.
Verified January 2014 by Nantes University Hospital
Sponsor:
Collaborator:
MAREP (Centre maladies rares Malformations Ano-Rectales Et Pelviennes)
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT02029248
First received: December 2, 2013
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Anorectal Malformation
Other: Quality of life questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: National Study on the Quality of Life of Patients With Anorectal Malformation (MARQOL)

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Kind of malformation, associated malformation, sequelas, handicap degree, social integration [ Time Frame: At the time of the inclusion ] [ Designated as safety issue: No ]
    Clinical questionnaire


Estimated Enrollment: 2000
Study Start Date: April 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Children 6-7
Patients who are between 6 and 7 years old
Other: Quality of life questionnaire
Children 8-11
Patients who are between 8 and 11 years old
Other: Quality of life questionnaire
Children 12-16
Patients who are between 12 and 16 years old
Other: Quality of life questionnaire
Patients 17-30
Patients who are between 17 and 30 years old
Other: Quality of life questionnaire

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.

  Eligibility

Ages Eligible for Study:   6 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02029248

Contacts
Contact: Guillaume Podevin, MD, PhD +33 (0)2 41 35 42 95 gupodevin@chu-angers.fr

Locations
France
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Stephan De Napoli Cocci, MD    02 40 08 35 85    stephan.denapolicocci@chu-nantes.fr   
Principal Investigator: Stephan De Napoli Cocci, MD         
Sponsors and Collaborators
Nantes University Hospital
MAREP (Centre maladies rares Malformations Ano-Rectales Et Pelviennes)
Investigators
Principal Investigator: Guillaume Podevin, MD, PhD CHU d'Angers (France)
  More Information

Publications:
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02029248     History of Changes
Other Study ID Numbers: BRD10/06-R
Study First Received: December 2, 2013
Last Updated: January 6, 2014
Health Authority: France: Commission nationale de l'informatique et des libertés

Keywords provided by Nantes University Hospital:
Anorectal malformation
fecal incontinence
quality of life
child

Additional relevant MeSH terms:
Congenital Abnormalities
Anus, Imperforate
Digestive System Abnormalities
Digestive System Diseases

ClinicalTrials.gov processed this record on April 20, 2014