๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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
๐
What it tests
- Diagnostic laparoscopy and inguinal mesh removal
- Diagnostic laparoscopy
Cleveland Clinic
Cleveland, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.