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

July 18, 2017 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

762

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens
      • Angers, France, 49033
        • CHU Angers
      • Besançon, France, 25030
        • CHU Besançon
      • Bordeaux, France, 33076
        • CHU Bordeaux
      • Brest, France, 29609
        • Chu Brest
      • Bron, France, 69677
        • Hospices Civils de Lyon
      • Caen, France, 14033
        • CHU Caen
      • Clermont-Ferrand, France, 63000
        • CHU Clermont-Ferrand
      • Colmar, France, 68024
        • Hôpitaux Civils de Colmar
      • Dijon, France, 21079
        • CHU Dijon
      • Fort-de-France (Martinique), France, 97261
        • CHU Fort-de-France
      • Grenoble, France, 38043
        • Chu Grenoble
      • Kremlin-Bicêtre, France, 94275
        • AP-HP Hôpital Bicêtre
      • Le Mans, France, 72037
        • CH Le Mans
      • Lille, France, 59037
        • CHRU Lille
      • Limoges, France, 87042
        • CHU Limoges
      • Marseille, France, 13915
        • AP-HM Hôpital Nord
      • Marseille, France, 13385
        • AP-HM La Timone
      • Montpellier, France, 34295
        • CHU Montpellier
      • Nantes, France, 44093
        • CHU de Nantes
      • Nice, France, 06200
        • CHU NICE
      • Orléans, France, 45032
        • CHR Orleans
      • Paris, France, 75019
        • AP-HP Hopital Robert Debré
      • Paris, France, 75012
        • AP-HP Hôpital Trousseau
      • Paris, France, 75015
        • AP-HP Hôpital Necker
      • Pointe-à-Pitre (Guadeloupe), France, 97159
        • CHU Pointe-à-Pître
      • Poitiers, France, 86021
        • CHU Poitiers
      • Reims, France, 51100
        • CHU Reims
      • Rennes, France, 35203
        • CHU Rennes
      • Rouen, France, 76031
        • CHU Rouen
      • Saint Brieuc, France, 22027
        • CH Saint Brieuc
      • Saint Denis (La Réunion), France, 97405
        • CHR La Réunion
      • Saint Etienne, France, 42055
        • CHU Saint Etienne
      • Strasbourg, France, 67098
        • CHRU Strasbourg
      • Toulouse, France, 31059
        • Chu Toulouse
      • Tours, France, 37044
        • CHRU Tours
      • Vandoeuvre-les-Nancy, France, 54511
        • CHU Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 28 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kind of malformation, associated malformation, sequelas, handicap degree, social integration
Time Frame: At the time of the inclusion
Clinical questionnaire
At the time of the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

MAREP ( Center For Rare Diseases Center Ano-Rectal And Pelvic Abnormalities)

Investigators

  • Principal Investigator: Guillaume Podevin, MD, PhD, CHU d'Angers (France)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

December 2, 2013

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD/10/06-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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