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 trial explores ways to manage ongoing groin pain that some people experience after minimally invasive hernia surgery. Researchers aim to determine if removing the mesh (a net-like material used in hernia repairs) can ease this type of pain compared to leaving the mesh in place. The trial involves a small incision procedure, known as diagnostic laparoscopy and inguinal mesh removal, to examine and possibly remove the mesh. It seeks participants who have experienced groin pain for more than six months since their hernia surgery, especially if the pain worsens when sitting or crossing their legs. As an unphased trial, this study offers participants the chance to contribute to understanding and improving post-surgical pain management.

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.

What prior data suggests that mesh removal surgery is safe for managing chronic groin pain?

Research shows that removing the mesh through a small incision, known as laparoscopic mesh removal, is generally safe for treating long-term groin pain after hernia surgery. Studies indicate that this procedure poses no major safety issues. However, some uncertainty remains about the risk of hernia recurrence after mesh removal. Most patients tolerate the procedure well, and it is considered effective for those with ongoing pain after previous hernia repair. Patients should consult a healthcare provider to determine if this option is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative approaches for addressing chronic groin pain after hernia surgery. Unlike typical pain management strategies that often involve medications or physical therapy, this trial investigates the potential benefits of diagnostic laparoscopy and the removal of problematic inguinal mesh. Diagnostic laparoscopy allows for a minimally invasive examination to identify any issues with mesh positioning or other sources of pain. The mesh removal process, which can be done laparoscopically or robotically, offers a direct method to potentially alleviate pain by addressing the root cause rather than just managing symptoms. This trial could pave the way for more effective, targeted treatments for patients who struggle with long-term pain after hernia repairs.

What evidence suggests that mesh removal surgery is effective for chronic groin pain?

This trial will compare two approaches for addressing chronic groin pain after hernia surgery: diagnostic laparoscopy and laparoscopic mesh removal. Research has shown that removing the mesh used in hernia surgery can be safe and beneficial for those experiencing ongoing pain post-operation. Studies have found that mesh removal can reduce pain for some patients who underwent a less invasive hernia repair. Many of these patients also reported an improved quality of life after the procedure. However, results can vary, and not everyone will experience the same level of pain relief. Overall, evidence suggests that mesh removal can alleviate long-term discomfort for certain patients. ^{2 3 5 6 7}

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

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 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]

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]

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]

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]

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]

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]

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 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]

Citations

1. frontierspartnerships.org frontierspartnerships.org/journals/journal-of-abdominal-wall-surgery/articles/10.3389/jaws.2025.15203/full

Quality of Life and Post-Operative Pain Following ... Laparoscopic inguinal hernia repair using self-fixating mesh has been associated with advantages such as reduced post-operative pain and fewer ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11933136/

Laparoscopic inguinal hernia repair with self-fixated meshes The Progrip™ mesh has been used with better outcomes in laparoscopic inguinal hernia surgery compared with fixated meshes in several studies [13 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36445507/

Laparoscopic mesh removal for chronic postoperative ... Laparoscopic mesh removal is safe and effective in selected patients with CPIP after endoscopic hernia repair.

4. sciencedirect.com sciencedirect.com/science/article/pii/S003960602500618X

Mesh removal in groin hernia surgery: A long-term ... The proportion of female groin hernia repairs was higher in the mesh removal group (15.2%) compared with the nonmesh removal group (7.9%).

5. ls.amegroups.org ls.amegroups.org/article/view/6635/html

Laparoscopic treatment of chronic pain following inguinal ... The use of mesh has dramatically reduced the risk of hernia recurrence (2) and the main clinical challenge has shifted towards postoperative chronic pain.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39528657/

Inguinal hernia recurrence after laparoscopic mesh ... Recent studies reported that laparoscopic mesh removal is feasible and safe. However, the risk of a hernia recurrence is unknown. This observational study ...

7. mdpi.com mdpi.com/2077-0383/14/17/6136

Chronic Groin Pain After Hernia Surgery: What Are We ... The widespread adoption of mesh-based techniques has led to a substantial reduction in recurrence rates—estimated at between 50% and 75% [1]. Consequently, ...