Umbilical Hernia
Conditions
Keywords
Umbilical Hernia
Brief 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. The appropriate data will be collected on day of surgery, and patients will be followed with a delayed parental submission of incisional photograph.
Interventions
PROCEDUREInfra-umbilical incision
Traditional curvilinear infra-umbilical incision is used to repair the umbilical hernia
PROCEDURETransumbilical incision
The incision for the repair of the umbilical hernia will be carried through the umbilicus itself.
Sponsors
Children's Mercy Hospital Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 9 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Umbilical hernia \> 1.5 cm in size * Patients with prior umbilical surgery * Subjects ≥10 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic Outcome | 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 . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative times | Up to 2 years | This will evaluate operative time for each procedure in minutes |
| Surgical site infections | 30 days | Assess the rate of surgical site infections in each arm of the study |
| Wound complications | 30 days | Evaluate wound complication including wound breakdown and wound dehiscence |
| Recurrence | 2 years | Recurrence of the umbilical hernia will be calculated as a rate in each arm |
Countries
United States
Outcome results
None listed