Actively Recruiting
Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Inguinal Hernia Repair
Led by David Krpata · Updated on 2025-10-06
70
Participants Needed
1
Research Sites
309 weeks
Total Duration
On this page
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Inguinal Hernia Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years of age
- Chronic postoperative inguinal pain lasting more than 6 months after laparoscopic or robotic inguinal hernia repair with pre-peritoneal mesh
- Exhibiting one or more nociceptive pain characteristics such as pain when sitting with relief on hip extension or lying down, severe pain when crossing the affected leg over the other, or feeling of tightness in the groin
- Diffuse tenderness with deep palpation along the inguinal ligament over the mesh
- No maximum trigger point for pain on somatosensory mapping
- Lacks neuropathic pain features like sharp, burning, or shooting pain
- Moderate to severe pain (score 4-10) when moving from lying to standing on the Numerical Rating Scale (NRS)
You will not qualify if you...
- No nociceptive groin pain characteristics
- Zero or mild pain (score 0-3) when moving from lying to standing on the Numerical Rating Scale
- Recurrent inguinal hernia detected on clinical exam
- Large femoral, direct, or indirect inguinal hernia classified as F2-3, M2-3, or L2-3 on diagnostic laparoscopy
- Prior open (anterior) inguinal hernia repair such as Lichtenstein technique
- Previous mesh plugs or Prolene Hernia Systems used
- History of prostatectomy or vascular surgery in the pelvis or groin
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
D
David Krpata, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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