Congenital Diaphragmatic HerniaNCT05985564
Retrospective Comparative Study on Imaging Between the Bochdalek Hernia and Congenital Diaphragmatic Eventration
An observational study of Congenital Diaphragmatic Hernia, run by Children's Hospital of Chongqing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Congenital Diaphragmatic Hernia
- What is being tested?
- imaging diagnosis
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- Clinical diagnosis of diaphragmatic hernia with surgical treatment
- Clinical diagnosis of congenital diaphragmatic eventration with surgical treatment
Who cannot join
- Diaphragmatic hernia or congenital diaphragmatic eventration without surgical treatment
- Diaphragmatic hernia or congenital diaphragmatic eventration without imaging examination
Trial locations and contacts
1 site in 1 country.
shi yuan contact
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Chongqing Medical University
Chongqing
song yan
About this study
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
- Conditions
- Congenital Diaphragmatic Hernia
- Being tested
- imaging diagnosis
- Medical subject headings
- Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imaging diagnosisOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| The Bochdalek hernia group | Not described Receives: Other: imaging diagnosis | |
| the congenital diaphragmatic eventration group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The position of the stomach
The position of the stomach through imaging examination and operation
Measured: 1 day during the test
The position of the small intestine
The position of the small intestine through imaging examination and operation
Measured: 1 day during the test
Secondary outcomes (3)
The morphology of the small intestine
The normal morphology, dilation and stenosis of the small intestine through imaging examination
Measured: 1 day during the test
The position of the colon
The position of the colon through imaging examination and operation
Measured: 1 day during the test
The morphology of the colon
The normal morphology, dilation and stenosis of the colon through imaging examination
Measured: 1 day during the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start18 Mar 2022
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yan song, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985564
- Sponsor's protocol ID
- ysong
- Status last verified
- Aug 2023
- First submitted
- 20 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26255159Brown 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.
PubMed 31414145Goodfellow 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.
PubMed 3676659
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Comparative Study on Imaging Between the Bochdalek Hernia and Congenital Diaphragmatic Eventration
- ClinicalTrials.gov ID
- NCT05985564
- Acronym / sponsor ID
- ysong
- Conditions
- Congenital Diaphragmatic Hernia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Bochdalek hernia group | – | Other: imaging diagnosis |
| the congenital diaphragmatic eventration group | – | – |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- Clinical diagnosis of diaphragmatic hernia with surgical treatment
- Clinical diagnosis of congenital diaphragmatic eventration with surgical treatment
Key exclusion criteria (2 listed)
- Diaphragmatic hernia or congenital diaphragmatic eventration without surgical treatment
- Diaphragmatic hernia or congenital diaphragmatic eventration without imaging examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imaging diagnosisno intervention | Other | The Bochdalek hernia group |
Primary outcome
The position of the stomach
Time frame: 1 day during the test
The position of the stomach through imaging examination and operation
The position of the small intestine
Time frame: 1 day during the test
The position of the small intestine through imaging examination and operation
3 secondary outcomes
The morphology of the small intestine
Time frame: 1 day during the test
The position of the colon
Time frame: 1 day during the test
The morphology of the colon
Time frame: 1 day during the test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 26255159Alamo 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.
- Background: PubMed 31414145Brown 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.
- Background: PubMed 3676659Goodfellow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shi yuan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Diaphragmatic Hernia, run by Children's Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact song yan (13637921652, doctorsongyan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The position of the stomach (time frame: 1 day during the test). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05985564, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.