🔎 Trials Near Me

Home › NCT05484635

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

RecruitingHealthy volunteers welcome

Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Minimally Invasive Inguinal Hernia Repair: A Randomized Controlled Trial

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Full eligibility 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

About the study

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.

What is being tested

Sponsor: David Krpata · Participants: 70 · Started: Jul 25, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05484635

Locations in the U.S.

OhioCleveland Clinic, Cleveland

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.