Occult Hernia Repair for Inguinal Hernia

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

252 Participants Needed

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.

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.

What data supports the effectiveness of the treatment Occult Hernia Repair for Inguinal Hernia?

Research shows that repairing occult (hidden) inguinal hernias during laparoscopic surgery can be beneficial, as these hidden hernias are often found during surgery and can be effectively treated at the same time, potentially preventing future complications. ^{1 2 3 4 5}

Is Occult Hernia Repair safe for humans?

Occult Hernia Repair, particularly through herniography (a type of imaging test), has been shown to be safe with no reported complications in studies. It is considered a safe procedure for evaluating and treating hidden hernias. ^{1 2 5 6 7}

How is the Occult Hernia Repair treatment different from other treatments for inguinal hernia?

Occult Hernia Repair is unique because it involves identifying and repairing hidden (occult) hernias that are not visible during a standard examination. This approach is often done during laparoscopic surgery, allowing surgeons to inspect both sides of the groin and address any hidden hernias simultaneously, potentially reducing the risk of recurrence and persistent symptoms. ^{1 4 5 8 9}

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.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

The incidence and natural course of occult inguinal hernias during TAPP repair: repair is beneficial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Management of Occult Contralateral Inguinal Hernia: Diagnosis and Treatment With Laparoscopic Totally Extra Peritoneal Repair. [2021]

3. England pubmed.ncbi.nlm.nih.gov

What's the SCORE? Current management of symptomatic, clinically occult, radiologically evident inguinal hernias. [2023]

4. Japan pubmed.ncbi.nlm.nih.gov

A study of the effectiveness of the bilateral and contralateral occult inguinal hernia repair by total extraperitoneal repair with intraperitoneal examination. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Contralateral exploration and repair of occult inguinal hernias during laparoscopic inguinal hernia repair: systematic review and Markov decision process. [2021]

6. England pubmed.ncbi.nlm.nih.gov

The incidence and analysis of ipsilateral occult hernia in patients undergoing hernia repair: a single institution retrospective study of 1066 patients. [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

Is herniography useful and safe? [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Occult inguinal hernia in the female. [2019]

9. India pubmed.ncbi.nlm.nih.gov

[Not Available]. [2021]