NCT05484635 · David Krpata
Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Inguinal Hernia Repair
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- \> 18 years of age
- CPIP lasting \> 6 months after laparoscopic or robotic inguinal hernia repair with pre-peritoneal mesh
- Must exhibit 1 or more of the following characteristics of nociceptive pain: History:
- Pain while sitting in a chair for prolonged periods of time with relief when extending the hip or lying supine to straighten the leg
- Severe pain when crossing the affected leg over the contralateral leg
- "Foreign body sensation" or "tightness" in the groin Exam: -Diffuse tenderness with deep palpation along the inguinal ligament (over the mesh) Somatosensory mapping:
- Does not have a maximum trigger point for pain
- Lacks characteristics of neuropathic pain (sharp, burning, shooting, paresthesias, allodynia, hyperalgesia, etc.)
- Moderate to severe pain \[4-10\] when moving from supine to standing on NRS
Exclusion criteria
- No characteristics of nociceptive groin pain
- Zero or mild pain \[0-3\] when moving from supine to standing on NRS
- Recurrent inguinal hernia detected on clinical exam
- Large, femoral, direct or indirect inguinal hernia (F2-3, M2-3, L2-3) on diagnostic laparoscopy as defined by European Hernia Society (EHS) classification
- Prior open (anterior) approach to inguinal hernia repair (i.e. Lichtenstein)
- Prior mesh plugs or Prolene Hernia Systems
- History of prostatectomy or vascular procedures in the pelvis or groin
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 6, 2025 · Source of record for eligibility and locations