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Procedure

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post-operative
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Assessment of chronic pain
Change in Abdominal wall quality of life (AW-QOL)
Groin pain on occult hernia side
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SurgeryExperimental Treatment1 Intervention
Occult hernia found will be repaired at the same time as the initial inguinal hernia
Group II: Expectant ManagementActive Control1 Intervention
No surgery will be done if an occult hernia is found during the initial inguinal hernia surgery

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,697 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
320 Previous Clinical Trials
401,450 Total Patients Enrolled

Media Library

Occult Hernia Repair (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04815707 — Phase 2
Inguinal Hernia Research Study Groups: Expectant Management, Surgery
Inguinal Hernia Clinical Trial 2023: Occult Hernia Repair Highlights & Side Effects. Trial Name: NCT04815707 — Phase 2
Occult Hernia Repair (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04815707 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment still recruiting participants?

"According to the clinicaltrials.gov records, this particular medical trial is currently not recruiting any new participants; it was first posted in August 2021 and most recently updated in May of the same year. Nevertheless, there are 164 other experiments that are still inviting patients to join their studies."

Answered by AI

Does this intervention possess the necessary regulatory authorization?

"Due to the lack of evidence supporting efficacy, this treatment was assigned a safety score of 2. Nevertheless, there is some data that demonstrates its security."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Lyndon B. Johnson General Hospital
Memorial Hermann Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have a hernia which needs surgery. Can you help me or do you know someone who can?
PatientReceived 2+ prior treatments
~101 spots leftby Oct 2025