Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT05484635
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05484635
Study Brief:
Protocol Section:
NCT05484635