Comparing cosmetic outcomes of different umbilical hernia repair techniques
Cosmetic Outcomes of Umbilical Hernia Incisions; A Randomized Controlled Trial
This study is testing which of two surgical methods for fixing umbilical hernias in kids under 10 leaves a better-looking scar.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | N/A to 9 Years |
| Sex | All |
| Sponsor | Children's Mercy Hospital Kansas City Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT06738121 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the cosmetic outcomes of two different surgical techniques for repairing umbilical hernias in children under 10 years of age. Patients will be randomly assigned to receive either an infra-umbilical incision or a transumbilical incision during their outpatient procedure. Data will be collected on the day of surgery, and parents will submit photographs of the incision site at a later date to assess cosmetic results. The study is being conducted at Children's Mercy Hospital in Kansas City.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 10 years old with umbilical hernias smaller than 1.5 cm.
Not a fit: Patients with umbilical hernias larger than 1.5 cm or those who have had prior umbilical surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the surgical technique that results in better cosmetic outcomes for children undergoing umbilical hernia repair.
How similar studies have performed: While there may be existing studies on umbilical hernia repairs, this specific comparison of incision techniques in a pediatric population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kansas City, Missouri
- Children's Mercy Hospital and Clinics — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Tolulope A Oyetunji, MD, MPH, MBA — Division Chief, Pediatric General Surgery
- Study coordinator: Tolulope A Oyetunji, MD, MPH, MBA
- Email: taoyetunji@cmh.edu
- Phone: (816) 234-3575
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.