Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Inguinal Hernia Repair
David Krpata · NCT05484635
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 70
- US sites recruiting
- 1
- Study start
- July 25, 2022
- Record last updated
- October 6, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the 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.
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.
Being studied: Diagnostic laparoscopy and inguinal mesh removal; Diagnostic laparoscopy
Conditions: Chronic Groin Pain; Hernia, Inguinal
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
Cleveland Clinic
Cleveland, OH 44195
Site contact: David Krpata, MD · 2164459989 · krpatad@ccf.org
Study contacts (from the official record)
- David Krpata, MD · 216-445-9989 · krpatad@ccf.org
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