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

Completed

• Conditions: Anorectal Malformations

• Registration Number: NCT05045560
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-30
• Status Verified: 2021-09
• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-09-06
• Study First Posted: 2021-09-16
• Last Update Submitted: 2021-09-18
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of ante or post-natal diagnosispremolars	1 day	Number of ante or post-natal diagnosis

Secondary Outcome Measures

Name	Time	Method
Number of with or without associated antenatal anomalies	1 day	Number of with or without associated antenatal anomalies

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France