Comparing mesh removal to no mesh removal for chronic groin pain after hernia repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the management of chronic groin pain following minimally invasive inguinal hernia repair, specifically assessing the effects of hernia mesh removal versus no removal. It is a double-blinded, randomized-controlled trial where participants may undergo diagnostic laparoscopy and could potentially have their mesh removed if they do not achieve adequate pain relief. Patients will be informed about the trial and can withdraw at any time. The study aims to determine if mesh removal leads to significant pain relief in patients suffering from chronic pain lasting more than six months.

Why it matters

Who can join: the full rules

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 it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: David Krpata, MD — The Cleveland Clinic
• Study coordinator: David Krpata, MD
• Email: krpatad@ccf.org
• Phone: 216-445-9989

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.