Incision Techniques for Umbilical Hernia

(UHR Trial)

Overseen By Emina Dizdarevic, MA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Hernia >1.5cm, Prior surgery, Age ≥10

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

170 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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. ^{1 2 3 4 8}

Research Team

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 Overview The 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

Group I: Traditional Infra-umbilical incision Active Control 1 Intervention

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

Group II: Vertical Trans-umbilical Incision Active Control 1 Intervention

Patients in this arm will have the cranio-caudal vertical incision right through the umbilicus for the repair of the umbilical hernia

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The intra-umbilical approach in umbilical hernia. Arslan, S., Korkut, E.[2020]

The inverted-U incisional technique for umbilicoplasty was found to produce significantly better aesthetic outcomes compared to the vertical oval incisional technique, as assessed by independent surgeons using a 5-point Likert scale.

Patients who underwent the inverted-U technique received a higher total aesthetic score (14.73) compared to those who had the vertical oval technique (11.26), indicating a more favorable perception of shape, size, depth, and natural appearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Aesthetic Outcomes of Umbilicoplasty in Breast Reconstruction with Abdominal Flap: Inverted-U Versus Vertical Oval Incision. Chung, JH., Kim, KJ., Sohn, SM., et al.[2021]

The minimal incision scar-less open umbilical hernia repair technique was performed on 20 patients with no postoperative complications, demonstrating its safety and effectiveness.

This technique resulted in no visible scarring and no hernia recurrences during an average follow-up of nearly 30 months, suggesting it offers a cosmetic advantage similar to laparoscopic methods while being cost-effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal incision scar-less open umbilical hernia repair in adults - technical aspects and short-term results. Zachariah, SK., Kolathur, NM., Balakrishnan, M., et al.[2020]

In a study of 122 patients undergoing ovarian cancer surgery, there was no significant difference in wound complication rates between those who had a transumbilical (TU) incision and those with a periumbilical (PU) incision.

Both incision types resulted in similar rates of complications such as wound infections and hernias, suggesting that avoiding the umbilicus during surgery does not provide any clinical advantage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of transumbilical and periumbilical median incisions in ovarian cancer surgery Yumru Çeliksoy, H., Cantürk, MM., Sözen, H., et al.[2023]

In a study of 150 patients who underwent reduced port colorectal surgery, the overall incidence of incisional hernia was low at 6%, indicating that this surgical approach is feasible and safe.

Obesity and pre-existing umbilical hernia were identified as significant risk factors for developing incisional hernia, with obesity increasing the risk by nearly six times and pre-existing hernia by over 160 times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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? Tschann, P., Lechner, D., Girotti, PNC., et al.[2022]

The Benz incision technique, an inverted Y-shaped umbilical incision, was successfully used in 75 pediatric patients for various surgical procedures without significant complications or increased operating time.

This technique not only allows for better access during surgery but also preserves the natural appearance of the umbilicus, making it a safe and effective option for reduced port surgery in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The umbilical Benz incision for reduced port surgery in pediatric patients. Amano, H., Uchida, H., Kawashima, H., et al.[2020]

References

1. Mexico pubmed.ncbi.nlm.nih.gov

Comparison of transumbilical approach versus infraumbilical incision for the repair of umbilical hernia in adults. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Transumbilical repair of umbilical hernia in children: The covert scar approach. [2019]

3. Turkey pubmed.ncbi.nlm.nih.gov

The intra-umbilical approach in umbilical hernia. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Aesthetic Outcomes of Umbilicoplasty in Breast Reconstruction with Abdominal Flap: Inverted-U Versus Vertical Oval Incision. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Minimal incision scar-less open umbilical hernia repair in adults - technical aspects and short-term results. [2020]

6. Turkey pubmed.ncbi.nlm.nih.gov

Comparison of transumbilical and periumbilical median incisions in ovarian cancer surgery [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

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]

8. United States pubmed.ncbi.nlm.nih.gov

The umbilical Benz incision for reduced port surgery in pediatric patients. [2020]