Mesh Removal for Chronic Groin Pain from Hernia Surgery

Overseen By David Krpata, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: David Krpata

Disqualifiers: Recurrent hernia, Large hernia, Prior open repair, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Immediate (surgical procedure)

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is evaluating the management of chronic post-operative inguinal hernia pain and the impact of hernia mesh removal after previous minimally invasive inguinal hernia repairs. The study aims are to evaluate the change in chronic (\>6 months), nociceptive, postoperative inguinal pain after mesh removal compared to no mesh removal in patients who have previously undergone minimally invasive inguinal hernia repair with pre-peritoneal mesh.

Will I have to stop taking my current medications?

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 mesh removal surgery for chronic groin pain after hernia repair safe?

Research indicates that laparoscopic mesh removal for chronic groin pain after hernia surgery is generally considered safe, with studies showing it is feasible and without serious complications in selected patients. ^{1 2 3 4 5}

How is the treatment of mesh removal for chronic groin pain after hernia surgery different from other treatments?

Mesh removal for chronic groin pain after hernia surgery is unique because it involves a laparoscopic procedure (a minimally invasive surgery using small incisions and a camera) to remove the mesh that may be causing pain, whereas other treatments might focus on managing pain without removing the mesh. This approach is considered when other treatments have failed and is seen as a feasible and potentially effective option for selected patients. ^{1 5 6 7 8}

What data supports the effectiveness of the treatment for mesh removal in chronic groin pain after hernia surgery?

Research shows that removing the mesh can help reduce chronic pain in some patients who have had hernia surgery. Studies indicate that laparoscopic (a minimally invasive surgery using small incisions) mesh removal is safe and may be effective for those with persistent pain after hernia repair. ^{1 7 8 9 10}

Who Is on the Research Team?

David Krpata, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults who've had laparoscopic or robotic inguinal hernia repair with mesh and suffer from moderate to severe chronic groin pain for over 6 months. They should feel pain when moving, sitting, or feeling a 'foreign body sensation' in the groin without signs of neuropathic pain. People with recurrent hernias, previous different mesh repairs, prostatectomy history, mild pain, or large hernias as per EHS classification can't join.

Inclusion Criteria

My pain does not feel sharp, burning, or increase with touch.

I feel like something is in my groin or it feels tight.

I experience pain when sitting for long but feel better when I stretch my leg or lie down.

Exclusion Criteria

My hernia is large and located in the groin area, as classified by the EHS.

I had open surgery for an inguinal hernia before.

Prior mesh plugs or Prolene Hernia Systems

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either diagnostic laparoscopy or laparoscopic mesh removal

Immediate (surgical procedure)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (in-person)

Optional Crossover

Participants may opt to crossover to the mesh removal group if inadequate pain relief is experienced

6 months or later

What Are the Treatments Tested in This Trial?

Interventions

• Diagnostic laparoscopy and inguinal mesh removal

Trial Overview The study compares two groups: one undergoing diagnostic laparoscopy only and another having both diagnostic laparoscopy and inguinal mesh removal. It aims to see if removing the mesh reduces chronic post-operative groin pain after minimally invasive hernia repair.

How Is the Trial Designed?

Group I: Laparoscopic mesh removal Experimental Treatment 1 Intervention

Minimally invasive incisions will be made, and a diagnostic laparoscopy will be performed. The surgeon will evaluate the mesh configuration, ensuring proper positioning, perform adhesiolysis if indicated for bowel involvement with the mesh and assess the abdomen for alternative sources of chronic pain. If randomized to mesh removal, laparoscopic or robotic preperitoneal mesh removal.

Group II: Diagnostic laparoscopy Active Control 2 Interventions

Minimally invasive incisions will be made, and a diagnostic laparoscopy will be performed. The surgeon will evaluate the mesh configuration, ensuring proper positioning, perform adhesiolysis if indicated for bowel involvement with the mesh and assess the abdomen for alternative sources of chronic pain.

Diagnostic laparoscopy and inguinal mesh removal is already approved in United States, European Union for the following indications:

Approved in United States as Diagnostic Laparoscopy and Inguinal Mesh Removal for:

• Chronic post-operative inguinal hernia pain

Approved in European Union as Diagnostic Laparoscopy and Inguinal Mesh Removal for:

• Chronic post-operative inguinal hernia pain

Who Is Running the Clinical Trial?

David Krpata

Lead Sponsor

Trials

1

Recruited

70+

Published Research Related to This Trial

In a study of 136 patients with chronic groin pain after Lichtenstein hernia repair, the removal of a meshoma or neuroma significantly increased the chances of successful pain relief, with odds ratios of 4.66 and 5.60, respectively.

Surgery performed under spinal anaesthesia was associated with better outcomes (OR 4.04), while preoperative opioid use was linked to less favorable results (OR 0.37), indicating that anaesthesia type and opioid use are important factors in surgical success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Determining Outcome After Surgery for Chronic Groin Pain Following a Lichtenstein Hernia Repair. Zwaans, WA., Verhagen, T., Roumen, RM., et al.[2018]

Laparoscopic mesh removal is a safe and effective procedure for patients experiencing chronic pain after endoscopic inguinal hernia repair, with no major complications reported in a study of 14 patients.

Post-surgery, patients experienced a significant reduction in pain scores from 8 to 4 after a median of 8 months, and 10 out of 14 patients reported good or excellent satisfaction with the outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic mesh removal for otherwise intractable inguinal pain following endoscopic hernia repair is feasible, safe and may be effective in selected patients. Slooter, GD., Zwaans, WAR., Perquin, CW., et al.[2019]

In a study of 44 patients undergoing laparoscopic mesh removal for chronic postoperative inguinal pain (CPIP), 68% reported complete or sufficient pain relief, indicating that this procedure is effective for managing CPIP after endoscopic hernia repair.

Laparoscopic mesh removal was found to be safe, with only a few intraoperative complications, although some patients experienced recurrent hernias post-surgery, suggesting careful patient selection is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic mesh removal for chronic postoperative inguinal pain following endoscopic hernia repair: a cohort study on the effect on pain. Slooter, CD., Perquin, CW., Zwaans, WA., et al.[2023]

A consensus algorithm for managing chronic inguinal postoperative pain (CPIP) was developed with input from 28 international experts, highlighting the need for structured guidelines in this area.

The algorithm emphasizes a multidisciplinary approach for CPIP management, recommending pharmacologic, behavioral, and interventional treatments, and suggests referral to specialized surgeons if conservative measures fail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An international consensus algorithm for management of chronic postoperative inguinal pain. Lange, JF., Kaufmann, R., Wijsmuller, AR., et al.[2021]

A combined laparoscopic and open surgical approach for treating chronic groin pain after open inguinal hernia repair showed good to excellent patient satisfaction in a study of 12 patients, with no intraoperative complications or infections.

All patients experienced significant improvement in their symptoms after the procedure, indicating that this method may be a preferred option for managing chronic neuralgia following previous hernia repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined open and laparoscopic approach to chronic pain following open inguinal hernia repair. Rosen, MJ., Novitsky, YW., Cobb, WS., et al.[2018]

Approximately 11% of patients experience chronic pain after mesh-based inguinal hernia repair, with over 25% of these individuals reporting moderate to severe pain, primarily due to neuropathic causes.

Chronic pain is less common in patients who undergo endoscopic repair or those who receive a lightweight mesh, suggesting that surgical technique and material choice can influence pain outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic pain after mesh repair of inguinal hernia: a systematic review. Nienhuijs, S., Staal, E., Strobbe, L., et al.[2022]

In a study of 79 young military men with unexplained groin pain, herniography was found to be a safe and reliable diagnostic tool, with 24% showing a positive result that was confirmed in 15 out of 16 patients who had surgery.

Although 76% of patients had a negative herniography, two out of eight who later underwent surgery were found to have an inguinal hernia, indicating that while herniography is effective, some cases may still require surgical exploration for confirmation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Herniography in 79 patients with unexplained pain in the groin: a retrospective study. Cohen, RH., Turkenburg, JL., van Dalen, A.[2019]

The Lichtenstein tension-free mesh repair technique for groin hernias is a safe and effective outpatient procedure that allows patients previously deemed unsuitable for surgery to undergo repair without significant risk of severe complications.

This method, performed under local anesthesia, enables quick recovery and return to work, helping to minimize overall healthcare costs while maintaining long-term success rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Lichtenstein repair. Kurzer, M., Belsham, PA., Kark, AE.[2015]

Chronic pain after hernia repair is more common than hernia recurrence, with identified risk factors including the type of repair, mesh characteristics, and early postoperative pain; for inguinal hernias, mesh-free techniques are comparable to mesh-based ones.

To prevent chronic pain, it is crucial to identify at-risk patients and use laparoscopic techniques with larger pore meshes and minimal fixation, as these strategies can significantly reduce the likelihood of developing chronic pain post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnostics and therapy of chronic pain following hernia operation]. Berger, D.[2022]

In a randomized clinical trial involving 394 patients, the use of self-fixating composite mesh for inguinal hernia repair resulted in similar pain levels compared to traditional sutured lightweight mesh, both during the initial recovery and one year later.

Chronic pain was reported by 36.3% of patients with self-fixating mesh and 34.1% with sutured mesh, indicating that neither method significantly reduced the risk of long-term discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized comparison of self-fixating and sutured mesh in open inguinal hernia repair. Pierides, G., Scheinin, T., Remes, V., et al.[2012]

Citations

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

Factors Determining Outcome After Surgery for Chronic Groin Pain Following a Lichtenstein Hernia Repair. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Laparoscopic mesh removal for otherwise intractable inguinal pain following endoscopic hernia repair is feasible, safe and may be effective in selected patients. [2019]

3. France pubmed.ncbi.nlm.nih.gov

Laparoscopic mesh removal for chronic postoperative inguinal pain following endoscopic hernia repair: a cohort study on the effect on pain. [2023]

4. France pubmed.ncbi.nlm.nih.gov

An international consensus algorithm for management of chronic postoperative inguinal pain. [2021]

5. France pubmed.ncbi.nlm.nih.gov

Combined open and laparoscopic approach to chronic pain following open inguinal hernia repair. [2018]

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

Chronic pain after mesh repair of inguinal hernia: a systematic review. [2022]

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

Herniography in 79 patients with unexplained pain in the groin: a retrospective study. [2019]

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

The Lichtenstein repair. [2015]

9. Germany pubmed.ncbi.nlm.nih.gov

[Diagnostics and therapy of chronic pain following hernia operation]. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Randomized comparison of self-fixating and sutured mesh in open inguinal hernia repair. [2012]