Pediatric DisorderNCT05852535
Spontaneous Evisceration of Infantile Umbilical Hernia
An observational study of Pediatric Disorder, run by Ahmed Kamel Ali Mohamed at 1 site in Egypt.
Trial summary
Infantile umbilical hernia is common in children. It has a regressive course in most cases. Conservative management is the standard in most cases before the age of 3 years unless there are complications such as incarceration, rupture with evisceration which are extremely rare and warrants emergency surgery. Read more about this study
- Who is it for?
- Ages 1 month to 3 years, men only
- Conditions the study is for
- Pediatric Disorder
- What is being tested?
- Exploration
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 7 May 2023to 24 May 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 1 month to 3 years
- Men only
- Child
Study population: pediatric age group
Who may be able to join
- Pediatric group
Who cannot join
- Adult group
Trial locations and contacts
1 site in 1 country.
About this study
Infantile umbilical hernia is common in children. It has a regressive course in most cases. Conservative management is the standard in most cases before the age of 3 years unless there are complications such as incarceration, rupture with evisceration which are extremely rare and warrants emergency surgery.
We present a rare case of a 6-month-old child with sudden spontaneous evisceration of infantile umbilical hernia.
Read the detailed description
Infantile umbilical hernia is common in children. It has a regressive course in most cases. Conservative management is the standard in most cases before the age of 3 years unless there are complications such as incarceration, rupture with evisceration which are extremely rare and warrants emergency surgery.
We present a rare case of a 6-month-old child with sudden spontaneous evisceration of infantile umbilical hernia.
- Conditions
- Pediatric Disorder
- Being tested
- Exploration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExplorationProcedure or surgery
abdominal exploration
| Study group | Role | What they receive |
|---|---|---|
| case report | Not described Receives: Procedure: Exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital stay
hospital stay
Measured: From April 1, 2023 to April 1, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start7 May 2023 (estimated)
- Primary completion23 May 2023 (estimated)
- Study completion24 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric DisorderStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Kamel Ali Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Kamel Ali Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852535
- Sponsor's protocol ID
- AKA171292
- Status last verified
- May 2023
- First submitted
- 24 Apr 2023
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spontaneous Evisceration of Infantile Umbilical Hernia
- ClinicalTrials.gov ID
- NCT05852535
- Acronym / sponsor ID
- AKA171292
- Conditions
- Pediatric Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Ahmed Kamel Ali MohamedUniversity, hospital or other
- Study start
- 7 May 2023 (estimated)
- Primary completion
- 23 May 2023 (estimated)
- Study completion
- 24 May 2023 (estimated)
- First posted
- 10 May 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.
Infantile umbilical hernia is common in children. It has a regressive course in most cases. Conservative management is the standard in most cases before the age of 3 years unless there are complications such as incarceration, rupture with evisceration which are extremely rare and warrants emergency surgery.
We present a rare case of a 6-month-old child with sudden spontaneous evisceration of infantile umbilical hernia.
Detailed description
Infantile umbilical hernia is common in children. It has a regressive course in most cases. Conservative management is the standard in most cases before the age of 3 years unless there are complications such as incarceration, rupture with evisceration which are extremely rare and warrants emergency surgery.
We present a rare case of a 6-month-old child with sudden spontaneous evisceration of infantile umbilical hernia.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| case report | – | Procedure: Exploration |
Who may qualify
- Ages
- 1 month to 3 years
- Sex
- Male only
- Age groups
- Child
- Study population
- pediatric age group
Key inclusion criteria (1 listed)
- Pediatric group
Key exclusion criteria (1 listed)
- Adult group
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 |
|---|---|---|
| Explorationabdominal exploration | Procedure or surgery | case report |
Primary outcome
hospital stay
Time frame: From April 1, 2023 to April 1, 2024
hospital stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pediatric Disorder, run by Ahmed Kamel Ali Mohamed at 1 site in Egypt.
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 1 inclusion and 1 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 10 May 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospital stay (time frame: From April 1, 2023 to April 1, 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2023.