Occult Hernia Repair for Inguinal Hernia

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: The University of Texas Health Science Center, Houston

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?Inguinal hernias are a common surgical problem. Best management of occult inguinal hernias, defined as hernias unable to be felt on physical exam, is unknown. From prior studies we know that most inguinal hernias will eventually become symptomatic and require surgery (70%). However, doing a repair on a very small, occult hernia may open the patient up to surgical complications, like chronic pain, earlier than necessary. This will be a multi-center randomized controlled trial of surgical repair versus expectant management of occult inguinal hernias. Patients undergoing laparoscopic unilateral inguinal hernia repair will be included. At the time of surgery, the surgeon will determine if there is an occult hernia contralateral side. If present, patients will be randomized to repair of the occult side or expectant management of the occult side. After 1 year post-operative data has been assessed, a decision tool will be created and administered to patients to aid in their decision making about treatments for their hernia.

Eligibility Criteria

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.

I am 18 years old or older.

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.

+1 more

Participant Groups

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.

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