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Laparascopic vs. Laparotomy Management of Neonatal Duodenal Atresia

NCT ID: NCT06115226

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-13

Study Completion Date

2023-12-31

Brief Summary

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Congenital duodenal atresia is a common cause of neonatal obstruction affecting 1 in 5000-10000 neonates. Laparoscopic management of this malformation is becoming increasingly common. However, few comparative studies exist and are often monocentric including few patients. This study will be multicentric, international and comparative to determine the place of laparoscopic surgery in the management of congenital duodenal atresia.

Detailed Description

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Conditions

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Congenital Duodenal Atresia

Keywords

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Congenital duodenal atresia Neonatal obstruction Laparascopic Laparotomy Neonatal duodenal atresia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Minor subject
* Subject having undergone neonatal surgery for congenital duodenal atresia or stenosis in the different participating centers between January 2009 and December 2019
* Subject (and/or his/her parental authority) who has not expressed, after information, his/her opposition to the reuse of his/her data for the purpose of this research

Criteria for non-inclusion:

* Subject (and/or his/her parental authority) who has indicated, after information, his/her opposition to the re-use of his/her data for the purposes of this research
* Conversion linked to a renunciation of the surgeon, procedure not started (optical introduction, unfeasibility by the surgeon due to lack of experience or technical impossibility)
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Chirurgie pédiatrique - CHU de Strasbourg - France

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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François BECMEUR, MD, PhD

Role: CONTACT

Phone: 33.3.88.12.73.07

Email: [email protected]

Facility Contacts

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François BECMEUR, MD, PhD

Role: primary

Other Identifiers

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7712

Identifier Type: -

Identifier Source: org_study_id