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Mesh Removal for Chronic Groin Pain After Hernia Repair

This study is for people experiencing chronic groin pain (pain lasting over 6 months) after having inguinal (groin) hernia repair surgery with mesh. Researchers want to see if removing the mesh helps reduce this pain. You would be randomly assigned to one of two groups: either diagnostic laparoscopy and inguinal mesh removal (a surgical procedure to explore and remove the mesh) or diagnostic laparoscopy (a surgical exploration without removing the mesh). The main goal is to measure how much your pain changes 6 months after surgery. To join, you must be over 18 and have specific types of pain after your hernia repair. The study is currently unclear on its status, but plans to enroll 70 participants.

Study design
This is a randomized, controlled study where you would be assigned to one of two groups, and you would not know which treatment you are receiving. It plans to include 70 participants.
What's involved
You would undergo either diagnostic laparoscopy with mesh removal or diagnostic laparoscopy without mesh removal. Your pain levels will be measured at baseline and 6 months after surgery.
Compensation
Not stated in the trial record.
Follow-up
Your pain will be measured 6 months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05484635

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

Recruiting
NAAges 18+InterventionalTreatment
David Krpata
~70 participants
Updated 2025-10-06 on ClinicalTrials.gov
What's tested:Diagnostic laparoscopy and inguinal mesh removalDiagnostic laparoscopy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Numerical Rating Scale (NRS-11)
Measured over Change in NRS-11 scores will be measured from baseline to 6 months after surgery for both groups.

Conditions

Chronic Groin Pain
Hernia, Inguinal

Explore related trials

Inguinal HerniaInguinal pain

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • David Krpata, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

David Krpata, MD
[email protected]
216-445-9989
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

\> 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:
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
Diffuse tenderness with deep palpation along the inguinal ligament (over the mesh)
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

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

What this trial measures

  • Numerical Rating Scale (NRS-11)Change in NRS-11 scores will be measured from baseline to 6 months after surgery for both groups.

    NRS-11 is a validated, 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) and is commonly used to measure Chronic Post-operative Inguinal Pain (CPIP). NRS-11 categorizes pain as none \[0\], mild \[1-3\], moderate \[4-6\], and severe \[7-10\]. Patients will be asked to select the single number that best represents their groin pain intensity when moving from a supine to standing position.