Study of Antenatal and Postnatal Data of Anorectal Malformations Diagnosed at Montpellier University Hospital Over a 10-year Period (2010-2020)

NCT05045560 | Completed

• 1 other identifier: RECHMPL20_0616
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Objective : Anorectal malformations (ARMs) are part of a spectrum of malformations due to an abnormal separation between the urogenital and digestive tracts during embryonic life. The prevalence of ARM is 1/2000 - 1/5000 live births, making it a relatively common malformation. The impact of an ARM depends mainly on the type of malformation, which can be difficult to evaluate in the antenatal period, and whether it is isolated or associated (50-80%) with other malformations or genetic syndromes. Only 1 to 16% of ARMs are diagnosed in the antenatal period. The objective of this study is to compare cases of prenatal diagnosis of ARM, cases of postnatal diagnosis of ARM with other antenatal ultrasound abnormalities, and those with normal antenatal ultrasound, in terms of management and functional prognosis, to identify ways to improve prenatal counseling. Materials and methods : In this retrospective monocentric study, the investigators have included all fetuses and newborns born between January 2010 and September 2020 with anorectal malformations, diagnosed from postnatal radiological examinations and surgical or autopsy reports at the University Hospital of Montpellier. The Krickenbeck classification was used to classify the ARMs and to assess the functional prognosis.

Conditions

Anorectal Malformations

Outcome Measures

Primary Outcomes (1)

• Number of ante or post-natal diagnosispremolars

  Number of ante or post-natal diagnosis

  1 day

Secondary Outcomes (1)

• Number of with or without associated antenatal anomalies

  1 day

Study Arms (3)

antenatal diagnosis of anorectal malformation

Groupe 1 : antenatal diagnosis of anorectal malformation

postnatal diagnosis of anorectal malfiormation with associated anomalies on antenatal ultrasound

Groupe 2 : postnatal diagnosis of anorectal malfiormation with associated anomalies on antenatal ultrasound

postnatal diagnosis of anorectal malformation with anormal antenatal ultrasound

Groupe 3 : postnatal diagnosis of anorectal malformation with anormal antenatal ultrasound

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all fetuses and newborns born between January 2010 and September 2020 with anorectal malformations, diagnosed from postnatal radiological examinations and surgical or autopsy reports at the University Hospital of Montpellier.

You may qualify if:

• fetuses and newborns born between January 2010 and September 2020 with anorectal malformations
• diagnosed from postnatal radiological examinations and surgical or autopsy reports at the University Hospital of Montpellier.

You may not qualify if:

• foreign-born patient
• anorectal malformation associated with an abdominal wall defect

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: NONE RETAINED

NC

MeSH Terms

Conditions

Anorectal Malformations

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Florent Fuchs, MD; PHD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 16, 2021
• Study Start: January 1, 2010
• Primary Completion: August 1, 2021
• Study Completion: August 30, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

FR (1)