National Study on the Quality of Life of Patients With Anorectal Malformation

NCT02029248 | Completed

• 1 other identifier: BRD/10/06-R
• Study Type: observational
• Target: 762
• Locations: 1 country
• Sites: 37

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.

Conditions

Anorectal Malformation

Keywords

Anorectal malformation; fecal incontinence; quality of life; child

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (1)

• Kind of malformation, associated malformation, sequelas, handicap degree, social integration

  At the time of the inclusion

Study Arms (4)

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

Interventions

Quality of life questionnaire OTHER

Children 12-16; Children 6-7; Children 8-11; Patients 17-30

Eligibility Criteria

• Age: 6 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients who are between 6 and 30 years old
• Patients initially treated in a french pediatric surgery service for anorectal malformation

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nantes University Hospital: lead
• MAREP ( Center For Rare Diseases Center Ano-Rectal And Pelvic Abnormalities): collaborator

Study Sites (37)

CHU Amiens

Amiens, 80054, France

Location

CHU Angers

Angers, 49033, France

Location

CHU Besançon

Besançon, 25030, France

Location

CHU Bordeaux

Bordeaux, 33076, France

Location

CHU Brest

Brest, 29609, France

Location

Hospices Civils de Lyon

Bron, 69677, France

Location

CHU Caen

Caen, 14033, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Hôpitaux Civils de Colmar

Colmar, 68024, France

Location

CHU Dijon

Dijon, 21079, France

Location

CHU Fort-de-France

Fort-de-France (Martinique), 97261, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

AP-HP Hôpital Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

CH Le Mans

Le Mans, 72037, France

Location

CHRU Lille

Lille, 59037, France

Location

CHU Limoges

Limoges, 87042, France

Location

AP-HM La Timone

Marseille, 13385, France

Location

AP-HM Hôpital Nord

Marseille, 13915, France

Location

CHU Montpellier

Montpellier, 34295, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CHU Nice

Nice, 06200, France

Location

CHR Orléans

Orléans, 45032, France

Location

AP-HP Hôpital Trousseau

Paris, 75012, France

Location

AP-HP Hôpital Necker

Paris, 75015, France

Location

AP-HP Hôpital Robert Debré

Paris, 75019, France

Location

CHU Pointe-à-Pitre

Pointe-à-Pitre (Guadeloupe), 97159, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

CHU Reims

Reims, 51100, France

Location

CHU Rennes

Rennes, 35203, France

Location

CHU Rouen

Rouen, 76031, France

Location

CHR La Réunion

Saint Denis (La Réunion), 97405, France

Location

CH Saint Brieuc

Saint-Brieuc, 22027, France

Location

CHU Saint Etienne

Saint-Etienne, 42055, France

Location

CHRU Strasbourg

Strasbourg, 67098, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

CHRU Tours

Tours, 37044, France

Location

CHU Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (4)

• Clermidi P, Podevin G, Cretolle C, Sarnacki S, Hardouin JB. The challenge of measuring quality of life in children with Hirschsprung's disease or anorectal malformation. J Pediatr Surg. 2013 Oct;48(10):2118-27. doi: 10.1016/j.jpedsurg.2013.03.071.

  PMID: 24094967 BACKGROUND

• Mantoo S, Meurette G, Wyart V, Hardouin J, Cretolle C, Capito C, Sarnacki S, Podevin G, Lehur PA. The impact of anorectal malformations on anorectal function and social integration in adulthood: report from a national database. Colorectal Dis. 2013 Jun;15(6):e330-5. doi: 10.1111/codi.12186.

  PMID: 23464709 BACKGROUND

• Podevin G, Petit T, Mure PY, Gelas T, Demarche M, Allal H, Becmeur F, Varlet F, Philippe P, Weil D, Heloury Y. Minimally invasive surgery for anorectal malformation in boys: a multicenter study. J Laparoendosc Adv Surg Tech A. 2009 Apr;19 Suppl 1:S233-5. doi: 10.1089/lap.2008.0137.supp.

  PMID: 18973467 BACKGROUND

• Fleury J, Picherot G, Cretolle C, Podevin G, David A, Caillon J, Roze JC, Gras-le Guen C. Currarino syndrome as an etiology of a neonatal Escherichia coli meningitis. J Perinatol. 2007 Sep;27(9):589-91. doi: 10.1038/sj.jp.7211783.

  PMID: 17724455 BACKGROUND

MeSH Terms

Conditions

Anorectal Malformations; Fecal Incontinence

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases

Study Officials

• Guillaume Podevin, MD, PhD

  CHU d'Angers (France)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: January 7, 2014
• Study Start: April 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

FR (37)