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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Infra-umbilical incision | Active Comparator | Patients randomized to this arm with have the traditional curvilinear 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infra-umbilical incision | Procedure | Traditional curvilinear infra-umbilical incision is used to repair the umbilical hernia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 . | 4 - 6 weeks and 2 years post operation |
| Measure | Description | Time Frame |
|---|---|---|
| Operative times | This will evaluate operative time for each procedure in minutes | Up to 2 years |
| Surgical site infections | Assess the rate of surgical site infections in each arm of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tolulope A Oyetunji, MD, MPH, MBA | Division Chief, Pediatric General Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospital and Clinics | Kansas City | Missouri | 64118 | United States |
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| ID | Term |
|---|---|
| D006554 | Hernia, Umbilical |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006555 | Hernia, Ventral |
| D046449 | Hernia, Abdominal |
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| Transumbilical incision | Procedure | The incision for the repair of the umbilical hernia will be carried through the umbilicus itself. |
|
| 30 days |
| Wound complications | Evaluate wound complication including wound breakdown and wound dehiscence | 30 days |
| Recurrence | Recurrence of the umbilical hernia will be calculated as a rate in each arm | 2 years |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |