Diaphragmatic Eventration in Children : Evaluation of Care Strategies and Results in the French Cohort.

NCT ID: NCT04862494

Last Updated: 2021-04-28

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-31

Study Completion Date

2022-06-30

Brief Summary

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A diaphragmatic eventration is an abnormal and permanent elevation of a portion or an entire intact hemidiaphragm. This rare pathology, found in 0.2 - 1 for every 1000 patients in large radiological series, is either congenital or acquired due to phrenic nerve palsy.

Most diaphragmatic eventrations are asymptomatic and discovered thanks to chest x-rays, where the diaphragmatic dome is elevated and visualized above the 4th intercostal space and sometimes up to the clavicle. Computed tomography or magnetic resonance imaging confirms the eventration by visualizing the diaphragmatic muscle distended and intact, unlike a diaphragmatic rupture or hernia.

Surgical indications are usually due to respiratory disorders or visceral repercussions, such as gastric emptying disorders or acute accidents like gastric volvulus. Surgical treatment is a phrenic plication, which can be performed via a lateral thoracotomy (classical approach), thoracoscopy or laparoscopy.

When surgery is not indicated, follow up consists of regular clinical and radiological monitoring.

There is, however, no consensus when it comes to their medical and surgical management due to the very low number of patients per center and per year, and the fact that very few studies specifically address this subject in the literature.

Detailed Description

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This is a retrospective multicenter descriptive cohort study based on French national healthcare data. The aim of this study is to describe the current trends in management of diaphragmatic eventrations in France in order to indentify potential risk factors for complications and to improve and homogenize practices.

Conditions

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Diaphragmatic Eventration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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diaphragmatic eventation with medical surveillance

Patients with a diagnosis of diaphragmatic eventration without respiratory or digestive consequences, thus not requiring surgical repair.

clinical surveillance

Intervention Type OTHER

regular clinical follow up including chest X-rays, pulmonary investigations, etc...

diaphragmatic eventration treated with plication

Patients with a diagnosis of diaphragmatic eventration with respiratory or digestive repercussion, requiring surgical repair.

diaphragmatic plication

Intervention Type PROCEDURE

plication of a hemidiaphragm, performed via laparoscopy, thoracoscopy (including robot-assisted surgery), or classical thoracotomy

Interventions

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clinical surveillance

regular clinical follow up including chest X-rays, pulmonary investigations, etc...

Intervention Type OTHER

diaphragmatic plication

plication of a hemidiaphragm, performed via laparoscopy, thoracoscopy (including robot-assisted surgery), or classical thoracotomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients of 16 years of age and under at diagnosis with diaphragmatic eventration, treated since 2010 in a pediatric surgery care unit in France.

Exclusion Criterion:

* Patients with a diaphragmatic hernia
* Patient's parents or legual guardian opposed to being included in the study.
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume Podevin, MD-PhD

Role: STUDY_DIRECTOR

University Hospital of Angers

Central Contacts

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Françoise Schmitt, MD-PhD

Role: CONTACT

+33241354290

References

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Heng L, Alzahrani K, Montalva L, Podevin G, Schmitt F; PedDiaVen collaboration group. Congenital Diaphragmatic Eventration: Should we Maintain Surgical Treatment? A Retrospective Multicentric Cohort Study. J Pediatr Surg. 2025 Jan;60(1):161991. doi: 10.1016/j.jpedsurg.2024.161991. Epub 2024 Oct 10.

Reference Type DERIVED
PMID: 39442326 (View on PubMed)

Other Identifiers

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2021-013

Identifier Type: -

Identifier Source: org_study_id

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