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Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Inguinal Hernia Repair

David Krpata · NCT05484635

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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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Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After… (NCT05484635) | Bored Studies