Management of Esophageal Atresia With Right Aortic Arch:... | NCT06402682

Studies
Management of Esophageal Atresia With Right Aortic Arch: Is the Side of Approach Important?

NCT06402682

Sponsor

Fondation Lenval

Status

Unknown status

Last Update Posted

May 22, 2024Actual

Enrollment

19Estimated

Phase

Not provided

Conditions

Right Aortic Arch

Interventions

Right approach
Left approach

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2024Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

May 3, 2024

First Submission Date that Met QC Criteria

May 3, 2024

First Posted Date

May 7, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2024

Last Update Posted Date

May 22, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Right approach			Procedure: Right approach
Left approach			Procedure: Left approach

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Right approach	Procedure	Right approach of the management of esophageal atresia with a right aortic arch	Right approach

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-operative complications	Post-operative complications after Esophageal atresia repair	During the first 40 post-operative days

Secondary Outcomes

Measure	Description	Time Frame
specific complications	Specific complications related to esophageal atresia and right aortic arch repair. The secondary outcome assessment was based on the declaration of clinical post-operative complications on patients medical file"	During the first 40 post-operative days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Having been operated on for esophageal atresia and right aortic arch

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jourisse Meye, MD	Contact	+33767332556		meye.j@chu-nice.fr
Jean-François Lecompte, MD	Contact			jean-francois.lecompte@hpu.lenval.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondation Lenval	Recruiting	Nice		06200	France