Comparing laparoscopic and open surgery for neonatal duodenal atresia
Laparascopic vs. Laparotomy Management of Neonatal Duodenal Atresia
This study is trying to see if laparoscopic surgery is better than open surgery for newborns with a blockage in their intestines caused by duodenal atresia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT06115226 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of laparoscopic surgery versus traditional laparotomy in managing congenital duodenal atresia, a condition that causes neonatal obstruction. It will be conducted across multiple international centers, gathering data from neonates who underwent surgery for this condition between 2009 and 2019. The goal is to provide a comprehensive analysis of outcomes associated with both surgical approaches, addressing the current lack of comparative studies in this area.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates who have undergone surgery for congenital duodenal atresia or stenosis in the participating centers.
Not a fit: Patients who have not undergone surgery for congenital duodenal atresia or whose surgery was not completed due to technical difficulties may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help establish laparoscopic surgery as a preferred method for treating congenital duodenal atresia, potentially leading to better patient outcomes.
How similar studies have performed: While few comparative studies exist, this multicentric approach aims to fill a gap in the literature, suggesting that the findings could be novel and impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Strasbourg
- Service de Chirurgie pédiatrique - CHU de Strasbourg - France — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: François BECMEUR, MD, PhD
- Email: francois.Becmeur@chru-strasbourg.fr
- Phone: 33.3.88.12.73.07
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.