Trial record 1 of 2 for:    "Anorectal atresia"
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National Study on the Quality of Life of Patients With Anorectal Malformation (MARQOL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 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: July 9, 2014
Last verified: July 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: October 2015
Estimated Primary Completion Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Amiens Recruiting
Amiens, France, 80054
Contact: Philippe Buisson, MD         
Principal Investigator: Philippe Buisson, MD         
CHU Angers Recruiting
Angers, France, 49033
Contact: Guillaume Podevin, MD         
Principal Investigator: Guillaume Podevin, MD         
CHU Besançon Recruiting
Besançon, France, 25030
Contact: Frédéric Auber, MD         
Principal Investigator: Frédéric Auber, MD         
CHU Bordeaux Recruiting
Bordeaux, France, 33076
Contact: Frédéric Lavrand, MD         
Principal Investigator: Frédéric Lavrand, MD         
CHU Brest Recruiting
Brest, France, 29609
Contact: Philine DeVries, MD         
Principal Investigator: Philine DeVries, MD         
Hospices Civils de Lyon Recruiting
Bron, France, 69677
Contact: Pierre-Yves Mure, MD         
Principal Investigator: Pierre-Yves Mure, MD         
CHU Caen Recruiting
Caen, France, 14033
Contact: Thierry Petit, MD         
Principal Investigator: Thierry Petit, MD         
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63000
Contact: Thierry Scheye, MD         
Principal Investigator: Thierry Scheye, MD         
Hôpitaux Civils de Colmar Recruiting
Colmar, France, 68024
Contact: Stephan Geiss, MD         
Principal Investigator: Stephan Geiss, MD         
CHU Dijon Recruiting
Dijon, France, 21079
Contact: Emmanuel Sapin, MD         
Principal Investigator: Emmanuel Sapin, MD         
CHU Fort-de-France Recruiting
Fort-de-France (Martinique), France, 97261
Contact: Jean-François Colombani, MD         
Principal Investigator: Jean-François Colombani, MD         
CHU Grenoble Recruiting
Grenoble, France, 38043
Contact: Christian Piolat, MD         
Principal Investigator: Christian Piolat, MD         
AP-HP Hôpital Bicêtre Recruiting
Kremlin-Bicêtre, France, 94275
Contact: Sophie Branchereau, MD         
Principal Investigator: Sophie Branchereau, MD         
CH Le Mans Recruiting
Le Mans, France, 72037
Contact: Pauline Clermidi, MD         
Principal Investigator: Pauline Clermidi, MD         
CHRU Lille Recruiting
Lille, France, 59037
Contact: Rémi Besson, MD         
Principal Investigator: Rémi Besson, MD         
CHU Limoges Recruiting
Limoges, France, 87042
Contact: Laurent Fourcade, MD         
Principal Investigator: Laurent Fourcade, MD         
AP-HM Hôpital Nord Recruiting
Marseille, France, 13915
Contact: Thierry Merrot, MD         
Principal Investigator: Thierry Merrot, MD         
AP-HM La Timone Recruiting
Marseille, France, 13385
Contact: Claude Borrione, MD         
Principal Investigator: Claude Borrione, MD         
CHU Montpellier Recruiting
Montpellier, France, 34295
Contact: Nicolas Kalfa, MD         
Principal Investigator: Nicolas Kalfa, MD         
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         
CHU Nice Recruiting
Nice, France, 06200
Contact: Florence Bastiani, MD         
Principal Investigator: Florence Bastiani, MD         
CHR Orléans Recruiting
Orléans, France, 45032
Contact: Myriam Pouzac, MD         
Principal Investigator: Myriam Pouzac, MD         
AP-HP Hôpital Necker Recruiting
Paris, France, 75015
Contact: Célia Crétolle, MD         
Principal Investigator: Célia Crétolle, MD         
AP-HP Hôpital Robert Debré Recruiting
Paris, France, 75019
Contact: Christine Grapin, MD         
Principal Investigator: Christine Grapin, MD         
AP-HP Hôpital Trousseau Recruiting
Paris, France, 75012
Contact: Henri Kotobi, MD         
Principal Investigator: Henri Kotobi, MD         
CHU Pointe-à-Pitre Recruiting
Pointe-à-Pitre (Guadeloupe), France, 97159
Contact: Christophe Laplace, MD         
Principal Investigator: Christophe Laplace, MD         
CHU Poitiers Recruiting
Poitiers, France, 86021
Contact: Guillaume Levard, MD         
Principal Investigator: Guillaume Levard, MD         
CHU Reims Recruiting
Reims, France, 51100
Contact: Marie-Laurence Poli-Mérol, MD         
Principal Investigator: Marie-Laurence Poli-Mérol, MD         
CHU Rennes Recruiting
Rennes, France, 35203
Contact: Alexis Arnaud, MD         
Principal Investigator: Alexis Arnaud, MD         
CHU Rouen Recruiting
Rouen, France, 76031
Contact: Agnès Liard, MD         
Principal Investigator: Agnès Liard, MD         
CH Saint Brieuc Recruiting
Saint Brieuc, France, 22027
Contact: Cynthia Garignon, MD         
Principal Investigator: Cynthia Garignon, MD         
CHR La Réunion Recruiting
Saint Denis (La Réunion), France, 97405
Contact: Frédérique Sauvat, MD         
Principal Investigator: Frédérique Sauvat, MD         
CHU Saint Etienne Recruiting
Saint Etienne, France, 42055
Contact: François Varlet, MD         
Principal Investigator: François Varlet, MD         
CHRU Strasbourg Recruiting
Strasbourg, France, 67098
Contact: François Becmeur, MD         
Principal Investigator: François Becmeur, MD         
CHU Toulouse Recruiting
Toulouse, France, 31059
Contact: Luana Carfagna, MD         
Principal Investigator: Luana Carfagna, MD         
CHRU Tours Recruiting
Tours, France, 37044
Contact: Hubert Lardy, MD         
Principal Investigator: Hubert Lardy, MD         
CHU Nancy Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: Jean-Louis Lemelle, MD         
Principal Investigator: Jean-Louis Lemelle, 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: July 9, 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 August 28, 2014