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Incision Techniques for Umbilical Hernia (UHR Trial)
N/A
Recruiting
Led By Tolulope A Oyetunji, MD, MPH, MBA
Research Sponsored by Children's Mercy Hospital Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient presenting with umbilical hernia that is <1.5cm in size based on physical exam for outpatient repair
Subjects <10 years of age
Must not have
Umbilical hernia > 1.5 cm in size
Patients with prior umbilical surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 - 6 weeks and 2 years post operation
Awards & highlights
No Placebo-Only Group
Summary
This trial will involve patients coming in for umbilical hernia repair. They will be randomly assigned to receive different types of repair. Data will be collected on the day of surgery, and patients will
Who is the study for?
This trial is for outpatients needing umbilical hernia repair who meet the study's requirements and have parental consent. Specific eligibility details are not provided, but typically include factors like age, health status, and type of hernia.
What is being tested?
The trial is comparing two surgical techniques for umbilical hernia repair: infra-umbilical incision versus transumbilical incision. It's a prospective, randomized controlled study where patients are assigned to a technique by chance.
What are the potential side effects?
Potential side effects are not detailed in the information provided but may include typical post-surgical issues such as pain at the incision site, risk of infection, scarring, and complications related to healing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have an umbilical hernia smaller than 1.5cm.
Select...
I am under 10 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an umbilical hernia larger than 1.5 cm.
Select...
I have had surgery on my belly button before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 - 6 weeks and 2 years post operation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 - 6 weeks and 2 years post operation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cosmetic Outcome
Secondary study objectives
Operative times
Recurrence
Surgical site infections
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Traditional Infra-umbilical incisionActive Control1 Intervention
Patients randomized to this arm with have the traditional curvilinear infra-umbilical incision
Group II: Vertical Trans-umbilical IncisionActive Control1 Intervention
Patients in this arm will have the cranio-caudal vertical incision right through the umbilicus for the repair of the umbilical hernia
Find a Location
Who is running the clinical trial?
Children's Mercy Hospital Kansas CityLead Sponsor
257 Previous Clinical Trials
940,326 Total Patients Enrolled
Tolulope A Oyetunji, MD, MPH, MBAPrincipal InvestigatorDivision Chief, Pediatric General Surgery