170 Participants Needed

Incision Techniques for Umbilical Hernia

(UHR Trial)

TA
ED
Overseen ByEmina Dizdarevic, MA
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Children's Mercy Hospital Kansas City
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this 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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for umbilical hernia repair using different incision techniques?

Research shows that using a transumbilical incision for umbilical hernia repair can hide scars within the belly button, improving cosmetic outcomes. Additionally, smaller incisions, like the intra-umbilical approach, may enhance patient satisfaction by being less visible and more practical.12345

Is the incision technique for umbilical hernia repair generally safe?

Research shows that different incision techniques for umbilical hernia repair, like transumbilical and infraumbilical incisions, are commonly used and generally considered safe. These techniques are often chosen for their aesthetic benefits and practicality, with no major safety concerns reported in the studies.12367

How does the incision technique for umbilical hernia differ from other treatments?

The transumbilical incision technique for umbilical hernia repair is unique because it hides the scar within the belly button, offering a more aesthetically pleasing result compared to the traditional infraumbilical incision, which leaves a visible scar.12348

Research Team

TA

Tolulope A Oyetunji, MD, MPH, MBA

Principal Investigator

Division Chief, Pediatric General Surgery

Eligibility Criteria

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.

Inclusion Criteria

I have an umbilical hernia smaller than 1.5cm.
Treated at CMH Adele Hall or CMHK from 09/11/24 - 09/11/25
I am under 10 years old.

Exclusion Criteria

I have an umbilical hernia larger than 1.5 cm.
I have had surgery on my belly button before.
I am 10 years old or older.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive umbilical hernia repair surgery with either a traditional infra-umbilical incision or a vertical trans-umbilical incision

1 day
1 visit (in-person)

Follow-up

Participants are monitored for cosmetic outcomes, surgical site infections, and wound complications

4-6 weeks
Delayed parental submission of incisional photograph

Long-term Follow-up

Participants are assessed for cosmetic outcomes and recurrence of the umbilical hernia

2 years

Treatment Details

Interventions

  • Infra-umbilical incision
  • Transumbilical incision
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials
261
Recruited
941,000+

Findings from Research

In a study of 82 patients with umbilical hernias, the transumbilical surgical approach resulted in significantly better cosmetic outcomes compared to the infra-umbilical approach, with most patients rating their results as good.
Both surgical techniques had similar complication rates, with no reported recurrences or mortality, indicating that the transumbilical approach is a safe and effective option for umbilical hernia repair.
Comparison of transumbilical approach versus infraumbilical incision for the repair of umbilical hernia in adults.Prieto-Díaz Chávez, E., Medina-Chávez, JL., Avalos-Cortes, LO., et al.[2018]
The transumbilical hernia repair technique was performed on 134 children and resulted in a low complication rate of 7.44%, indicating it is a safe option for umbilical hernia repairs.
Parents reported a high satisfaction rate of 97.52% regarding the cosmetic outcome, suggesting that this technique is not only effective but also improves the aesthetic results compared to traditional methods.
Transumbilical repair of umbilical hernia in children: The covert scar approach.Pallister, ZS., Angotti, LM., Patel, VK., et al.[2019]
The intra-umbilical incision technique for umbilical hernia repair was performed on eight patients, showing that it is aesthetically superior to traditional methods, enhancing patient satisfaction.
In cases where the hernia defect was smaller than 4 cm, the intra-umbilical incision was sufficient, while larger defects required an extension of the incision, indicating that this technique is practical for various sizes of hernias.
The intra-umbilical approach in umbilical hernia.Arslan, S., Korkut, E.[2020]

References

Comparison of transumbilical approach versus infraumbilical incision for the repair of umbilical hernia in adults. [2018]
Transumbilical repair of umbilical hernia in children: The covert scar approach. [2019]
The intra-umbilical approach in umbilical hernia. [2020]
A Comparison of Aesthetic Outcomes of Umbilicoplasty in Breast Reconstruction with Abdominal Flap: Inverted-U Versus Vertical Oval Incision. [2021]
Minimal incision scar-less open umbilical hernia repair in adults - technical aspects and short-term results. [2020]
Comparison of transumbilical and periumbilical median incisions in ovarian cancer surgery [2023]
Incidence and risk factors for umbilical incisional hernia after reduced port colorectal surgery (SIL + 1 additional port)-is an umbilical midline approach really a problem? [2022]
The umbilical Benz incision for reduced port surgery in pediatric patients. [2020]