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

April 22, 2021 updated by: University Hospital, Angers

Paediatric Treatment of Diaphragmatic Eventrations in France: Management Strategies and Long-term Results : an Observational Study.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

100

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

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

No older than 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

National cohort of all pediatric patients diagnosed with or operated for diaphragmatic eventration since January, 1st, 2010, in a pediatric surgical care unit in France. Patients will be devided into non operated and operated patients for outcome comparisons.

Description

Inclusion Criterion:

  • 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.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
diaphragmatic eventation with medical surveillance
Patients with a diagnosis of diaphragmatic eventration without respiratory or digestive consequences, thus not requiring surgical repair.
Other: clinical surveillance
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.
Procedure: diaphragmatic plication
plication of a hemidiaphragm, performed via laparoscopy, thoracoscopy (including robot-assisted surgery), or classical thoracotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the level of asymptomatic patients diagnosed with diaphragmatic eventration depending on the type of treatment (surgical or not).
Time Frame: Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age
Asymptomatic patient rate defined as patients presenting without any digestive, respiratory or orthopaedic symptom.
Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the occurrence of lung disease in patients with non treated diaphragmatic eventrations
Time Frame: Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age
Objectified by pulmonary function tests (PFTs), carried out according to the ATS/ERS-GLI (American Thoracic Society and European Respiratory Society-Global Lung Initiative) recommendations.
Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age
To assess the rate of digestive symptoms in patients with diaphragmatic eventrations.
Time Frame: Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age
Clinical assessment of digestive symptoms linked to diaphragmatic eventration and/or to diaphragmatic plication, such à GERD, dumping syndrom, digestive occlusion or pain (scored by visual analogic scale).
Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age
To assess the occurrence of orthopaedic impact of non treated diaphragmatic eventrations
Time Frame: Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age
objectified by the deformation of the spine on chest x-ray measured by the Cobb angle.
Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age
To assess the severity rate of postoperative complications
Time Frame: Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age
Description of postoperative complications encountered after diaphragmatic plication, scored with the Clavien-Dindo classification.
Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age

Collaborators and Investigators

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

Sponsor

University Hospital, Angers

Investigators

  • Study Director: Guillaume Podevin, MD-PhD, University hospital of Angers

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 (Anticipated)

May 1, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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