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

Description

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.

Conditions

Chronic Groin Pain, Hernia, Inguinal

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Chronic Groin Pain
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • * 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
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

David Krpata,

David Krpata, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2026-01-01