Cosmetic Outcomes of Umbilical Hernia Incisions

Not Applicable

Recruiting

• Conditions: Umbilical Hernia

• Registration Number: NCT06738121
• Lead Sponsor: Children's Mercy Hospital Kansas City

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Study Start: 2025-05
• Primary Completion: 2025-11-01
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Children's Mercy Hospital and Clinics; 🇺🇸 Kansas City, Missouri, United States