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

NCT04862494 | Unknown

• 1 other identifier: 2021-013
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diaphragmatic Eventration

Keywords

thoracoscopy; laparoscopy; digestive disorders; restrictive syndrom

Outcome Measures

Primary Outcomes (1)

• To assess the level of asymptomatic patients diagnosed with diaphragmatic eventration depending on the type of treatment (surgical or not).

  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 Outcomes (4)

• To assess the occurrence of lung disease in patients with non treated diaphragmatic eventrations

  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.

  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

  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

  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

Study Arms (2)

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

diaphragmatic eventration treated with plication

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

Procedure: diaphragmatic plication

Interventions

clinical surveillance OTHER

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

diaphragmatic eventation with medical surveillance

diaphragmatic plication PROCEDURE

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

diaphragmatic eventration treated with plication

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Hospital, Angers: lead

Related Publications (1)

• 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.

  PMID: 39442326 DERIVED

MeSH Terms

Conditions

Diaphragmatic Eventration; Digestive System Diseases

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Guillaume Podevin, MD-PhD

  University Hospital of Angers

  STUDY DIRECTOR

Central Study Contacts

Françoise Schmitt, MD-PhD

CONTACT

+33241354290; FrSchmitt@chu-angers.fr

Study Design

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

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 28, 2021
• Study Start: May 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share