Cosmetic Outcomes of Umbilical Hernia Incisions (UHR)

August 18, 2025 updated by: Tolulope Oyetunji, Children's Mercy Hospital Kansas City

Cosmetic Outcomes of Umbilical Hernia Incisions; A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64118
        • Children's Mercy Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional Infra-umbilical incision
Patients randomized to this arm with have the traditional curvilinear infra-umbilical incision
Procedure: Infra-umbilical incision
Traditional curvilinear infra-umbilical incision is used to repair the umbilical hernia
Active Comparator: Vertical Trans-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
The incision for the repair of the umbilical hernia will be carried through the umbilicus itself.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cosmetic Outcome
Time Frame: 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 .
4 - 6 weeks and 2 years post operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative times
Time Frame: Up to 2 years
This will evaluate operative time for each procedure in minutes
Up to 2 years
Surgical site infections
Time Frame: 30 days
Assess the rate of surgical site infections in each arm of the study
30 days
Wound complications
Time Frame: 30 days
Evaluate wound complication including wound breakdown and wound dehiscence
30 days
Recurrence
Time Frame: 2 years
Recurrence of the umbilical hernia will be calculated as a rate in each arm
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Tolulope A Oyetunji, MD, MPH, MBA, Division Chief, Pediatric General Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2025

Primary Completion (Actual)

April 23, 2025

Study Completion (Actual)

April 23, 2025

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

December 17, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003347

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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