Cosmetic Outcomes of Umbilical Hernia Incisions

NCT06738121 | Completed

• 1 other identifier: STUDY00003347
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Umbilical Hernia

Keywords

Umbilical Hernia

Outcome Measures

Primary Outcomes (1)

• Cosmetic Outcome

  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 Outcomes (4)

• Operative times

  Up to 2 years

• Surgical site infections

  30 days

• Wound complications

  30 days

• Recurrence

  2 years

Study Arms (2)

Traditional Infra-umbilical incision

ACTIVE COMPARATOR

Patients randomized to this arm with have the traditional curvilinear infra-umbilical incision

Procedure: Infra-umbilical incision

Vertical Trans-umbilical Incision

ACTIVE COMPARATOR

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

Interventions

Infra-umbilical incision PROCEDURE

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

Traditional Infra-umbilical incision

Transumbilical incision PROCEDURE

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

Vertical Trans-umbilical Incision

Eligibility Criteria

• Age: Up to 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Umbilical hernia \> 1.5 cm in size
• Patients with prior umbilical surgery
• Subjects ≥10 years of age

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital and Clinics

Kansas City, Missouri, 64118, United States

Location

MeSH Terms

Conditions

Hernia, Umbilical

Condition Hierarchy (Ancestors)

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

Study Officials

• Tolulope A Oyetunji, MD, MPH, MBA

  Division Chief, Pediatric General Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 17, 2024
• Study Start: March 20, 2025
• Primary Completion: April 23, 2025
• Study Completion: April 23, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)