NCT05985564

Brief Summary

The imaging manifestations of diaphragmatic hernia and diaphragmatic distension were retrospectively analyzed and summarized, combined with the surgical findings, to summarize the differences in indirect signs of diaphragmatic hernia and diaphragmatic distension, so as to achieve the purpose of differential diagnosis.Research contents: (1) To summarize the characteristics of indirect imaging signs in patients with diaphragmatic hernia, to sum up the incidence of each sign, to find new signs and the prognosis of each sign; (2) Summarize the characteristics of indirect imaging signs in patients with diaphragmatic distension, summarize the incidence of each sign, and search for new signs and the prognosis of each sign; (3) To summarize the differences in indirect signs of diaphragmatic hernia and diaphragmatic distension, as well as the differences in their incidence, and combined with their surgical findings, to summarize their image identification points

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

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 18, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

1.6 years

First QC Date

July 20, 2023

Last Update Submit

August 9, 2023

Conditions

Congenital Diaphragmatic Hernia

Outcome Measures

Primary Outcomes (2)

  • The position of the stomach

    The position of the stomach through imaging examination and operation

    1 day during the test

  • The position of the small intestine

    The position of the small intestine through imaging examination and operation

    1 day during the test

Secondary Outcomes (3)

  • The morphology of the small intestine

    1 day during the test

  • The position of the colon

    1 day during the test

  • The morphology of the colon

    1 day during the test

Study Arms (2)

The Bochdalek hernia group

Other: imaging diagnosis

the congenital diaphragmatic eventration group

Interventions

imaging diagnosisOTHER

no intervention

The Bochdalek hernia group

Eligibility Criteria

AgeUp to 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The Bochdalek hernia and the congenital diaphragmatic eventration were included in the study. They had undergone surgical treatment.The imaging results and the surgical results were analysis

You may qualify if:

  • Clinical diagnosis of diaphragmatic hernia with surgical treatment
  • Clinical diagnosis of congenital diaphragmatic eventration with surgical treatment

You may not qualify if:

  • Diaphragmatic hernia or congenital diaphragmatic eventration without surgical treatment
  • Diaphragmatic hernia or congenital diaphragmatic eventration without imaging examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

Related Publications (3)

  • Alamo L, Gudinchet F, Meuli R. Imaging findings in fetal diaphragmatic abnormalities. Pediatr Radiol. 2015 Dec;45(13):1887-900. doi: 10.1007/s00247-015-3418-5. Epub 2015 Aug 9.

    PMID: 26255159BACKGROUND

  • Brown BP, Clark MT, Wise RL, Timsina LR, Reher TA, Vandewalle RJ, Brown JJ, Saenz ZM, Gray BW. A multifactorial severity score for left congenital diaphragmatic hernia in a high-risk population using fetal magnetic resonance imaging. Pediatr Radiol. 2019 Dec;49(13):1718-1725. doi: 10.1007/s00247-019-04478-2. Epub 2019 Aug 14.

    PMID: 31414145BACKGROUND

  • Goodfellow T, Hyde I, Burge DM, Freeman NV. Congenital diaphragmatic hernia: the prognostic significance of the site of the stomach. Br J Radiol. 1987 Oct;60(718):993-5. doi: 10.1259/0007-1285-60-718-993.

    PMID: 3676659BACKGROUND

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

Congenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

song yan

CONTACT

13637921652doctorsongyan@163.com

shi yuan

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 14, 2023

Study Start

March 18, 2022

Primary Completion

October 31, 2023

Study Completion

December 31, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)