Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Inguinal Hernia Repair
Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Minimally Invasive Inguinal Hernia Repair: A Randomized Controlled Trial
David Krpata
70 participants
Jul 25, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria13
- \> 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 Criteria7
- 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
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Interventions
Surgical examination and treatment of groin pain following inguinal hernia surgery by surgical exploration with a laparoscope or removal of mesh laparoscopically
Surgical examination through laparoscopy without removal of mesh
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05484635