Incisional HerniaNCT05005663
Incisional Hernia in Infants and Children
A study testing surgical management of incisional hernia in people with Incisional Hernia, run by Tanta University at 1 site in Egypt.
Trial summary
the study of development of incisional hernia in infants and children at a tertiary level experience. Read more about this study
- Who is it for?
- Ages 8 months to 18 years
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- surgical management of incisional hernia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2007to 22 Jan 2023
- Phase
- Interventional
- 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 8 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- all infants and children with incisional hernia
Who cannot join
- congenital abdominal wall defects
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Tanta, 31111
Nagi El-dessouky, neldesoky2000@yahoo.com
About this study
Official title: Incisional Hernia in Children and and Infants : a Tertiary Center Experience
the study of development of incisional hernia in infants and children at a tertiary level experience.
Read the detailed description
Background: incisional hernia in children and infants (IHCI) represents a major complication following exploration. The condition is associated with prolonged hospital stay, readmission and the need for another operation to treat the resulting incisional hernia. The incidence is variable worldwide. The leading causes are still indeterminate as well as the management strategy. We aimed at studying IHCI at a tertiary level hospital as regard presenting symptoms, methods of management and its impact on the quality of life of patients.
Methods: a retrospective study included all infants and children presented with incisional hernia. Patients were categorized in to two groups according to the age of presentation, group A patients younger than two years of age and group B patients older than two years. All data related to the first operation in addition to data related to repair of the incisional hernia were collected in special charts.
- Conditions
- Incisional Hernia
- Being tested
- surgical management of incisional hernia
- Keywords
- incisional hernia, infants, children, tissue repair, wound healing
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical management of incisional herniaOther
surgical repair of the incisional hernia
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | patients younger than 2 years Receives: Other: surgical management of incisional hernia |
| group B | Active comparator | patients older than 2 years Receives: Other: surgical management of incisional hernia |
What is being measured
The primary outcome is the main question the study is designed to answer.
repair of incisional hernia
surgical repair
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start2 Feb 2007
- Primary completion20 Dec 2022 (estimated)
- Study completion22 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Gharieb Mohammad Khirallah, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005663
- Sponsor's protocol ID
- 34687/5/21
- Status last verified
- Apr 2022
- First submitted
- 5 Aug 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incisional Hernia in Children and and Infants : a Tertiary Center Experience
- ClinicalTrials.gov ID
- NCT05005663
- Acronym / sponsor ID
- 34687/5/21
- Conditions
- Incisional Hernia
- Keywords
- incisional hernia, infants, children, tissue repair, wound healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 2 Feb 2007 (actual)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 22 Jan 2023 (estimated)
- First posted
- 13 Aug 2021 (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 study of development of incisional hernia in infants and children at a tertiary level experience.
Detailed description
Background: incisional hernia in children and infants (IHCI) represents a major complication following exploration. The condition is associated with prolonged hospital stay, readmission and the need for another operation to treat the resulting incisional hernia. The incidence is variable worldwide. The leading causes are still indeterminate as well as the management strategy. We aimed at studying IHCI at a tertiary level hospital as regard presenting symptoms, methods of management and its impact on the quality of life of patients.
Methods: a retrospective study included all infants and children presented with incisional hernia. Patients were categorized in to two groups according to the age of presentation, group A patients younger than two years of age and group B patients older than two years. All data related to the first operation in addition to data related to repair of the incisional hernia were collected in special charts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Other: surgical management of incisional herniapatients younger than 2 years |
| group B | Active comparator | Other: surgical management of incisional herniapatients older than 2 years |
Who may qualify
- Ages
- 8 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- all infants and children with incisional hernia
Key exclusion criteria (1 listed)
- congenital abdominal wall defects
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 |
|---|---|---|
| surgical management of incisional herniasurgical repair of the incisional hernia | Other | group A, group B |
Primary outcome
repair of incisional hernia
Time frame: 2 years
surgical repair
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical management of incisional hernia in people with Incisional Hernia, run by Tanta University 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 27 Apr 2022. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
repair of incisional hernia (time frame: 2 years). 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 27 Apr 2022.