Laparascopic vs. Laparotomy Management of Neonatal Duodenal Atresia

December 7, 2023 updated by: University Hospital, Strasbourg, France
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Chirurgie Pédiatrique - CHU de Strasbourg - France
        • Sub-Investigator:
          • Amane-Allah LACHKAR, MD
        • Sub-Investigator:
          • François LEFEBVRE, Statistician
        • Contact:
        • Principal Investigator:
          • François BECMEUR, MD, PhD
        • Sub-Investigator:
          • Isabelle TALON, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Minor subject having undergone neonatal surgery for congenital duodenal atresia or stenosis in the different participating centers between January 2009 and December 2019

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of complications
Time Frame: 3 months after laparoscopic surgery
3 months after laparoscopic surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2020

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

November 9, 2022

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7712

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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