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OpenTrials
Completed

NCT Number: NCT06738121

Cosmetic Outcomes of Umbilical Hernia Incisions

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.

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Key information

Conditions

Umbilical Hernia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Abdominal Hernia, Umbilical Hernia, Ventral Infant, Newborn, Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

Up to 9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Hospital and Clinics

Kansas City, Missouri, 64118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infra-umbilical incision

Procedure

Traditional curvilinear infra-umbilical incision is used to repair the umbilical hernia

transumbilical incision

Procedure

The incision for the repair of the umbilical hernia will be carried through the umbilicus itself.

Primary outcomes

  1. 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 .

Secondary outcomes

  1. Operative times

    Time frame: Up to 2 years

    This will evaluate operative time for each procedure in minutes

  2. Surgical site infections

    Time frame: 30 days

    Assess the rate of surgical site infections in each arm of the study

  3. Wound complications

    Time frame: 30 days

    Evaluate wound complication including wound breakdown and wound dehiscence

  4. Recurrence

    Time frame: 2 years

    Recurrence of the umbilical hernia will be calculated as a rate in each arm

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

Cosmetic Outcomes of Umbilical Hernia Incisions; A Randomized Controlled Trial

Acronym: UHR

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2024
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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