NCT06402682

Brief Summary

Esophageal atresia is associated with a right aortic arch in 2 to 13% of cases. Despite previous studies, consensus on the optimal surgical approach remains lacking. This study aims to analyze the management of esophageal atresia with a right aortic arch in France over three decades, to define the most effective surgical strategy and identify associated complications.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

May 3, 2024

Last Update Submit

May 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post-operative complications

    Post-operative complications after Esophageal atresia repair

    During the first 40 post-operative days

Secondary Outcomes (1)

  • specific complications

    During the first 40 post-operative days

Study Arms (2)

Right approach

Procedure: Right approach

Left approach

Procedure: Left approach

Interventions

Right approach of the management of esophageal atresia with a right aortic arch

Right approach
Left approachPROCEDURE

Left approach of the management of esophageal atresia with a right aortic arch

Left approach

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients born with esophageal atresia and right aortic arch between 1990 et 2022

You may qualify if:

  • Having been operated on for esophageal atresia and right aortic arch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Lenval

Nice, 06200, France

RECRUITING

Central Study Contacts

Jourisse Meye, MD

CONTACT

Jean-François Lecompte, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2024

First Posted

May 7, 2024

Study Start

March 15, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

May 22, 2024

Record last verified: 2024-05

Locations