An interventional study of Infra-umbilical incision and Transumbilical incision in Umbilical Hernia, sponsored by Children's Mercy Hospital Kansas City. Completed at 1 site in United States. Open to participants aged Up to 9 Years. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Children's Mercy Hospital Kansas City · Not applicable, Interventional, and Treatment
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.
67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.
This study's enrollment of 2 is below the median of 66 across 40 interventional studies indexed under Hernia, Umbilical.
Browse Hernia, Umbilical studies →Children's Mercy Hospital Kansas City is the lead sponsor of 210 studies on the registry; 20 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.
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Exclusion Criteria:
Patients randomized to this arm with have the traditional curvilinear infra-umbilical incision
Procedure: Infra-umbilical incision
Patients in this arm will have the cranio-caudal vertical incision right through the umbilicus for the repair of the umbilical hernia
Procedure: Transumbilical incision
Traditional curvilinear infra-umbilical incision is used to repair the umbilical hernia
The incision for the repair of the umbilical hernia will be carried through the umbilicus itself.
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 .
Time frame: 4 - 6 weeks and 2 years post operation
Operative times
This will evaluate operative time for each procedure in minutes
Time frame: Up to 2 years
Surgical site infections
Assess the rate of surgical site infections in each arm of the study
Time frame: 30 days
Wound complications
Evaluate wound complication including wound breakdown and wound dehiscence
Time frame: 30 days
Recurrence
Recurrence of the umbilical hernia will be calculated as a rate in each arm
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2025 to primary completion in Apr 2025, 1 month.
Of 19 interventional studies with no phase under Hernia, Umbilical, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 47. This study's 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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