Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Inguinal Hernia Repair
RecruitingNot applicableNCT05484635
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Minimally Invasive Inguinal Hernia Repair: A Randomized Controlled Trial
- Conditions
- Chronic Groin Pain
- Hernia, Inguinal
- Interventions
- Procedure: Diagnostic laparoscopy and inguinal mesh removal
- Procedure: Diagnostic laparoscopy
- Sponsor
- David Krpata
- Organization
- The Cleveland Clinic
- Start date
- 2022-07-25
- Primary completion
- 2027-12-31
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05484635