- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05985564
Retrospective Comparative Study on Imaging Between the Bochdalek Hernia and Congenital Diaphragmatic Eventration
August 9, 2023 updated by: yan song, Children's Hospital of Chongqing Medical University
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
300
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
- Name: song yan
- Phone Number: 13637921652
- Email: doctorsongyan@163.com
Study Contact Backup
- Name: shi yuan
Study Locations
-
-
-
Chongqing, China
- Recruiting
- Children's Hospital of Chongqing Medical University
-
Contact:
- song yan
-
-
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
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-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
Description
Inclusion Criteria:
- Clinical diagnosis of diaphragmatic hernia with surgical treatment
- Clinical diagnosis of congenital diaphragmatic eventration with surgical treatment
Exclusion Criteria:
- Diaphragmatic hernia or congenital diaphragmatic eventration without surgical treatment
- Diaphragmatic hernia or congenital diaphragmatic eventration without imaging examination
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
The Bochdalek hernia group
|
no intervention
|
the congenital diaphragmatic eventration group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The position of the stomach
Time Frame: 1 day during the test
|
The position of the stomach through imaging examination and operation
|
1 day during the test
|
The position of the small intestine
Time Frame: 1 day during the test
|
The position of the small intestine through imaging examination and operation
|
1 day during the test
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The morphology of the small intestine
Time Frame: 1 day during the test
|
The normal morphology, dilation and stenosis of the small intestine through imaging examination
|
1 day during the test
|
The position of the colon
Time Frame: 1 day during the test
|
The position of the colon through imaging examination and operation
|
1 day during the test
|
The morphology of the colon
Time Frame: 1 day during the test
|
The normal morphology, dilation and stenosis of the colon through imaging examination
|
1 day during the test
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
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 (Actual)
March 18, 2022
Primary Completion (Estimated)
October 31, 2023
Study Completion (Estimated)
December 31, 2023
Study Registration Dates
First Submitted
July 20, 2023
First Submitted That Met QC Criteria
August 9, 2023
First Posted (Actual)
August 14, 2023
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 9, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ysong
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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