Mesh Removal for Chronic Groin Pain from Hernia Surgery
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?
Is mesh removal surgery for chronic groin pain after hernia repair safe?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either diagnostic laparoscopy or laparoscopic mesh removal
Follow-up
Participants are monitored for safety and effectiveness after treatment
Optional Crossover
Participants may opt to crossover to the mesh removal group if inadequate pain relief is experienced
Treatment Details
Interventions
- Diagnostic laparoscopy and inguinal mesh removal
Diagnostic laparoscopy and inguinal mesh removal is already approved in United States, European Union for the following indications:
- Chronic post-operative inguinal hernia pain
- Chronic post-operative inguinal hernia pain
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Who Is Running the Clinical Trial?
David Krpata
Lead Sponsor