Occult Hernia Repair for Inguinal Hernia

Not currently recruiting at 2 trial locations

Overseen By Debbie F Lew, MPH, CCRC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Life expectancy <2 years, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best management for occult inguinal hernias, which cannot be detected during a physical exam. The study will compare two approaches: repairing the hernia during surgery or waiting to see if symptoms develop. Eligible participants are those undergoing laparoscopic surgery for an inguinal hernia who also have an unseen hernia on the opposite side. The goal is to assist patients and doctors in making informed decisions about hernia treatments by developing a decision tool based on the study's findings. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.

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. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that surgery for a hidden inguinal hernia can sometimes lead to complications. One study found that about 10.5% of patients who underwent this type of hernia repair experienced issues after surgery, such as ongoing pain.

While these numbers highlight some risks, evidence suggests that most people eventually require surgery for hernias when they begin causing noticeable problems. It's important to weigh the potential benefits of early repair against the risk of complications. Prospective trial participants can use this information to discuss options with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores two different approaches to managing occult hernias discovered during inguinal hernia surgery. Traditionally, inguinal hernias are repaired surgically when diagnosed. However, this trial is assessing whether it's beneficial to repair these hidden hernias immediately or to leave them untreated. This could lead to a more personalized approach to hernia management, potentially reducing unnecessary surgeries and associated risks.

What evidence suggests that this trial's treatments could be effective for inguinal hernia?

Research has shown that repairing hidden (occult) hernias can improve outcomes for individuals with groin (inguinal) hernias. In this trial, participants will join one of two groups: those undergoing surgery to repair the occult hernia alongside the initial inguinal hernia, and those receiving expectant management, where no surgery occurs if an occult hernia is found. Studies have found that individuals who undergo surgery often return to normal activities more quickly and report higher satisfaction than those who do not. However, repairing a hidden hernia can result in longer surgery times and an increased likelihood of hospital readmission. Most groin hernias eventually cause symptoms and require surgery, leading some experts to believe that early repair might be beneficial. Ultimately, deciding whether to repair a hidden hernia involves weighing the benefits of early treatment against the risks of surgery-related complications. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are already having laparoscopic surgery for an inguinal hernia and are found to have a hidden (occult) hernia on the other side. It's not for those unlikely to follow up, non-English or Spanish speakers, pregnant or breastfeeding individuals, or patients with a life expectancy of less than 2 years.

Inclusion Criteria

I am having laparoscopic surgery for a hernia and they found another hernia on the opposite side.

Exclusion Criteria

You are pregnant or currently breastfeeding.

I do not speak English or Spanish.

Your doctor thinks you may not live for more than 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Patients undergo laparoscopic unilateral inguinal hernia repair. If an occult hernia is found, patients are randomized to repair or expectant management.

Time of surgery

Post-operative Follow-up

Participants are monitored for progression of hernia signs or symptoms, chronic pain, and other outcomes.

1 year

Multiple visits for assessments

Long-term Follow-up

Participants are monitored for hernia recurrence, satisfaction with decision, and quality of life.

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Occult Hernia Repair

Trial Overview The study compares immediate surgical repair versus waiting and watching in managing small, undetectable inguinal hernias found during surgery. Participants will be randomly assigned to either get their occult hernia repaired right away or monitored without immediate repair.

How Is the Trial Designed?

Group I: Surgery Experimental Treatment 1 Intervention

Occult hernia found will be repaired at the same time as the initial inguinal hernia

Group II: Expectant Management Active Control 1 Intervention

No surgery will be done if an occult hernia is found during the initial inguinal hernia surgery

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40069471/

Incidence and clinical characteristics of occult inguinal ... Results: Intraoperative detection of occult inguinal hernias was observed in 225 patients (25.92%). Patients with occult inguinal hernia had a ...

2. publishing.rcseng.ac.uk publishing.rcseng.ac.uk/doi/10.1308/rcsann.2021.0211

What's the SCORE? Current management of symptomatic ... Patients reported an improved return to habitual activity, pain and satisfaction following inguinal hernia repair, compared with non-surgical ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40789772/

Quality of life outcomes of minimally invasive repair ... Conclusion: Occult contralateral hernia repair during TAPP inguinal repair was associated with longer operative time, higher readmission rate, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04815707

NCT04815707 | Treatment of Occult Inguinal Hernias This will be a multi-center randomized controlled trial of surgical repair versus expectant management of occult inguinal hernias.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/ases.12976

A study of the effectiveness of the bilateral and ... We aimed to estimate the incidence of bilateral and contralateral occult inguinal hernias in our surgical population and to compare the results ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7944513/

Contralateral exploration and repair of occult inguinal hernias ... Among patients who underwent repair, 10.5 (4.3–17.0) per cent experienced a postoperative complication.

7. scholarlycommons.hcahealthcare.com scholarlycommons.hcahealthcare.com/cgi/viewcontent.cgi?article=1004&context=gulfcoast2023

Natural History of Occult Hernias in Adults at a Safety-Net ... Our aim was to determine and report on the natural history of patients with occult hernias including the impact on AW-QOL, need for surgery, and risk of acute ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0011384019301376

Current strategies for the management of inguinal hernia 1, 2 The lifetime risk of developing a groin hernia is estimated at 27%-43% in men and 3%-6% in women,3 most of which will ultimately require repair.4 Operation ...