Cosmetic Outcomes of Umbilical Hernia Incisions

NCT ID: NCT06738121

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-20

Study Completion Date

2025-04-23

Brief Summary

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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.

Detailed Description

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Conditions

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Umbilical Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Traditional Infra-umbilical incision

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

Group Type ACTIVE_COMPARATOR

Infra-umbilical incision

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

Transumbilical incision

Intervention Type PROCEDURE

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

Interventions

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Infra-umbilical incision

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

Intervention Type PROCEDURE

Transumbilical incision

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Tolulope Oyetunji

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tolulope A Oyetunji, MD, MPH, MBA

Role: PRINCIPAL_INVESTIGATOR

Division Chief, Pediatric General Surgery

Locations

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Children's Mercy Hospital and Clinics

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00003347

Identifier Type: -

Identifier Source: org_study_id

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