70 Participants Needed

Mesh Removal for Chronic Groin Pain from Hernia Surgery

AC
DK
Overseen ByDavid Krpata, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: David Krpata
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 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.12345

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.26789

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.123910

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.

Research Team

DK

David Krpata, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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.
See 6 more

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
See 4 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Laparoscopic mesh removalExperimental Treatment1 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 laparoscopyActive Control2 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:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Diagnostic Laparoscopy and Inguinal Mesh Removal for:
  • Chronic post-operative inguinal hernia pain
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Diagnostic Laparoscopy and Inguinal Mesh Removal for:
  • Chronic post-operative inguinal hernia pain

Find a Clinic Near You

Who Is Running the Clinical Trial?

David Krpata

Lead Sponsor

Trials
1
Recruited
70+

Findings from Research

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.
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.
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.
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]

References

Factors Determining Outcome After Surgery for Chronic Groin Pain Following a Lichtenstein Hernia Repair. [2018]
Laparoscopic mesh removal for otherwise intractable inguinal pain following endoscopic hernia repair is feasible, safe and may be effective in selected patients. [2019]
Laparoscopic mesh removal for chronic postoperative inguinal pain following endoscopic hernia repair: a cohort study on the effect on pain. [2023]
An international consensus algorithm for management of chronic postoperative inguinal pain. [2021]
Combined open and laparoscopic approach to chronic pain following open inguinal hernia repair. [2018]
Chronic pain after mesh repair of inguinal hernia: a systematic review. [2022]
Herniography in 79 patients with unexplained pain in the groin: a retrospective study. [2019]
The Lichtenstein repair. [2015]
[Diagnostics and therapy of chronic pain following hernia operation]. [2022]
Randomized comparison of self-fixating and sutured mesh in open inguinal hernia repair. [2012]
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