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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods for repairing umbilical hernias, which are small bumps near the belly button caused by a weak spot in the abdominal wall. The study compares traditional infra-umbilical (below the belly button) and vertical trans-umbilical (through the belly button) incisions to determine which technique is more effective. It may suit children under 10 years old with an umbilical hernia less than 1.5 cm in size who require outpatient surgery. Participants will be randomly assigned to one of the two surgical methods, and researchers will closely monitor their recovery. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially improve surgical outcomes for children.

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 prior data suggests that these incision techniques are safe for umbilical hernia repair?

Research shows that both infra-umbilical and transumbilical incisions for umbilical hernia repair are generally safe and well-tolerated.

For the infra-umbilical incision, studies have found complications to be rare. One study noted that only 0.1% of surgeries experienced issues during the procedure, and 1.6% had problems afterward. These issues, such as fluid build-up, bruising, and wound infections, are uncommon.

The transumbilical incision is also considered safe. Research supports it as a good option, especially for children, with no increase in complications after surgery. The risk of problems, like hernia recurrence or cosmetic concerns, remains low, around 2%.

Both methods have proven to be safe, making them reliable choices for umbilical hernia repair. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing incision techniques for umbilical hernia repair because it explores two different surgical approaches that could improve patient outcomes. The traditional infra-umbilical incision method is a widely used technique, but the trial also investigates the vertical trans-umbilical incision, which is less common. This approach cuts directly through the umbilicus, potentially offering better cosmetic results and faster recovery. By understanding how these techniques compare, surgeons hope to refine the standard of care and enhance the overall surgical experience for patients.

What evidence suggests that these incision techniques are effective for umbilical hernia repair?

This trial will compare two incision techniques for umbilical hernia repair: the Traditional Infra-umbilical incision and the Vertical Trans-umbilical Incision. Research has shown that using mesh in umbilical hernia repairs results in fewer recurrences compared to suturing alone. For the traditional incision below the belly button, open repairs have lower recurrence rates than minimally invasive (laparoscopic) methods. However, the trans-umbilical method carries low risk, with only about 2% of surgeries resulting in complications or requiring additional repair. Both techniques are generally successful, but the choice may depend on individual patient needs and cosmetic preferences. Overall, these procedures are safe and effective for repairing umbilical hernias. ^{4 6 7 8 9}

Who Is on the Research Team?

Tolulope A Oyetunji, MD, MPH, MBA

Principal Investigator

Division Chief, Pediatric General Surgery

Are You a Good Fit for This Trial?

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 had surgery on my belly button before.

I am 10 years old or older.

I have an umbilical hernia larger than 1.5 cm.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12096569/

Exploration of umbilical hernia incidence and etiology in ...

This study aims to explore the occurrence of incisional hernias following single-port laparoscopic surgery and identify associated risk factors.

2.

emedicine.medscape.com

emedicine.medscape.com/article/2000990-technique

Umbilical Hernia Repair Technique

Open mesh repair of umbilical hernia appears to be associated with significantly lower recurrence rates than suture repair in adults.

3.

journals.lww.com

journals.lww.com/md-journal/fulltext/2018/09070/retrospective_analysis_of_smaller_than_3_cm.96.aspx

Retrospective analysis of smaller than 3-cm umbilical hernia

There is evidence that mesh repair for primary umbilical hernias results in fewer recurrences and similar wound complication rates compared to tissue repair.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1015958422008958

Open versus laparoscopic intraperitoneal on-lay mesh repair

There were no reported chronic pain or recurrence in the open IPOM group, but in the laparoscopic group there were 2 (4.9%) cases of chronic pain and 2 (4.9%) ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11182624/

UMBILICAL AND EPIGASTRIC HERNIA REPAIR

This review concluded that it is evident the superiority of the use of meshes in the repair of epigastric/primary umbilical hernias with a defect larger than 1 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11186979/

Emergency umbilical hernia management: scoping review

There were no reported long-term complications related to the presence of mesh reported in an RCT of 42 patients having emergency umbilical ...

7.

facs.org

facs.org/for-patients/the-day-of-your-surgery/adult-umbilical-hernia/

Adult Umbilical Hernia | ACS

If your hernia is not surgically repaired, there is a 4% risk that it can strangulate within the next five years. This means that your intestines can be ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0022346818305505

Transumbilical repair of umbilical hernia in children

The overall complication rate was 7.44%. Parents of 118 patients reported satisfaction with the cosmetic result (97.52%). In comparison to the largest study of ...

9.

bmcsurg.biomedcentral.com

bmcsurg.biomedcentral.com/articles/10.1186/s12893-025-02958-x

Exploration of umbilical hernia incidence and etiology in 753 ...

Intraoperative complications occurred in 0.1% of cases, while postoperative complications occurred in 1.6%. Incisional hernias developed in 10 ...