Umbilical HerniaUHRNCT06738121
Cosmetic Outcomes of Umbilical Hernia Incisions
A study testing Infra-umbilical incision and Transumbilical incision in people with Umbilical Hernia, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
This will be a single institution, prospective, randomized controlled trial. Patients presenting as an outpatient for repair of umbilical hernias who meet our inclusion criteria, whose parents provide permission to participate in the study, will receive the umbilical hernia repair that they are randomized to. Read more about this study
- Who is it for?
- Ages Up to 9 years
- Conditions the study is for
- Umbilical Hernia
- What is being tested?
- Infra-umbilical incision and Transumbilical incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2025to 23 Apr 2025
- 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 Up to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient presenting with umbilical hernia that is <1.5cm in size based on physical exam for outpatient repair
- Treated at CMH Adele Hall or CMHK from 09/11/24 - 09/11/25
- Subjects <10 years of age
Who cannot join
- Umbilical hernia > 1.5 cm in size
- Patients with prior umbilical surgery
- Subjects ≥10 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital and Clinics
Kansas City, Missouri, 64118
About this study
Official title: Cosmetic Outcomes of Umbilical Hernia Incisions; A Randomized Controlled Trial
This will be a single institution, prospective, randomized controlled trial. Patients presenting as an outpatient for repair of umbilical hernias who meet our inclusion criteria, whose parents provide permission to participate in the study, will receive the umbilical hernia repair that they are randomized to. The appropriate data will be collected on day of surgery, and patients will be followed with a delayed parental submission of incisional photograph.
- Conditions
- Umbilical Hernia
- Being tested
- Infra-umbilical incision, Transumbilical incision
- Keywords
- Umbilical Hernia
- Medical subject headings
- Hernia, Umbilical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infra-umbilical incisionProcedure or surgery
Traditional curvilinear infra-umbilical incision is used to repair the umbilical hernia
Transumbilical incisionProcedure or surgery
The incision for the repair of the umbilical hernia will be carried through the umbilicus itself.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Infra-umbilical incision | Active comparator | Patients randomized to this arm with have the traditional curvilinear infra-umbilical incision Receives: Procedure: Infra-umbilical incision |
| Vertical Trans-umbilical Incision | Active comparator | Patients in this arm will have the cranio-caudal vertical incision right through the umbilicus for the repair of the umbilical hernia Receives: Procedure: Transumbilical incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic Outcome
Cosmetic appearance of incision will be measured using the Pediatric Scar Assessment Questionnaire (PSAQ) filled out by patients and a modified version filled out by an independent assessor .
Measured: 4 - 6 weeks and 2 years post operation
Secondary outcomes (4)
Operative times
This will evaluate operative time for each procedure in minutes
Measured: Up to 2 years
Surgical site infections
Assess the rate of surgical site infections in each arm of the study
Measured: 30 days
Wound complications
Evaluate wound complication including wound breakdown and wound dehiscence
Measured: 30 days
Recurrence
Recurrence of the umbilical hernia will be calculated as a rate in each arm
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 posted17 Dec 2024
- Study start20 Mar 2025
- Primary completion23 Apr 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tolulope Oyetunji, Children's Mercy Hospital Kansas City
- Investigators
- Tolulope A Oyetunji, MD, MPH, MBA, Principal investigator, Division Chief, Pediatric General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738121
- Sponsor's protocol ID
- STUDY00003347
- Acronym
- UHR
- Status last verified
- Aug 2025
- First submitted
- 10 Dec 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cosmetic Outcomes of Umbilical Hernia Incisions; A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06738121
- Acronym / sponsor ID
- UHR / STUDY00003347
- Conditions
- Umbilical Hernia
- Keywords
- Umbilical Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 17 Dec 2024 (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.
This will be a single institution, prospective, randomized controlled trial. Patients presenting as an outpatient for repair of umbilical hernias who meet our inclusion criteria, whose parents provide permission to participate in the study, will receive the umbilical hernia repair that they are randomized to. The appropriate data will be collected on day of surgery, and patients will be followed with a delayed parental submission of incisional photograph.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Infra-umbilical incision | Active comparator | Procedure: Infra-umbilical incisionPatients randomized to this arm with have the traditional curvilinear infra-umbilical incision |
| Vertical Trans-umbilical Incision | Active comparator | Procedure: Transumbilical incisionPatients in this arm will have the cranio-caudal vertical incision right through the umbilicus for the repair of the umbilical hernia |
Who may qualify
- Ages
- Up to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patient presenting with umbilical hernia that is <1.5cm in size based on physical exam for outpatient repair
- Treated at CMH Adele Hall or CMHK from 09/11/24 - 09/11/25
- Subjects <10 years of age
Key exclusion criteria (3 listed)
- Umbilical hernia > 1.5 cm in size
- Patients with prior umbilical surgery
- Subjects ≥10 years of age
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 |
|---|---|---|
| Infra-umbilical incisionTraditional curvilinear infra-umbilical incision is used to repair the umbilical hernia | Procedure or surgery | Traditional Infra-umbilical incision |
| Transumbilical incisionThe incision for the repair of the umbilical hernia will be carried through the umbilicus itself. | Procedure or surgery | Vertical Trans-umbilical Incision |
Primary outcome
Cosmetic Outcome
Time frame: 4 - 6 weeks and 2 years post operation
Cosmetic appearance of incision will be measured using the Pediatric Scar Assessment Questionnaire (PSAQ) filled out by patients and a modified version filled out by an independent assessor .
4 secondary outcomes
Operative times
Time frame: Up to 2 years
Surgical site infections
Time frame: 30 days
Wound complications
Time frame: 30 days
Recurrence
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- 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.
Tolulope A Oyetunji, MD, MPH, MBA principal investigator
Division Chief, Pediatric General Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infra-umbilical incision and Transumbilical incision in people with Umbilical Hernia, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 22 Aug 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cosmetic Outcome (time frame: 4 - 6 weeks and 2 years post operation). 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 22 Aug 2025.