Occult Hernia Repair for Inguinal Hernia

Phase 2

Recruiting

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing unilateral laparoscopic inguinal hernia repair, found to have a contralateral occult inguinal hernia

Age 18 or older

Must not have

Non-English and Non-Spanish speakers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years post-operative

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether it is better to fix an inguinal hernia when it is found during surgery for another hernia, or to wait and see if it becomes symptomatic.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include typical surgical risks such as chronic pain at the site of the operation. Since some hernias may not cause symptoms immediately, early surgery could lead to experiencing these side effects sooner.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not speak English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post-operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient threshold value for need for future surgery in order to accept Expectant Management (EM) of an Occult Inguinal Hernia (OIH) determined using standard gamble technique

Secondary study objectives

Assessment of chronic pain

Change in Abdominal wall quality of life (AW-QOL)

Groin pain on occult hernia side

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