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Compares treatment options for Chronic Groin Pain
Official title Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Inguinal Hernia Repair
ClinicalTrials.gov ID: NCT05484635
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- \> 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
You likely can't join if
- 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)...
- Prior open (anterior) approach to inguinal hernia repair (i.e. Lichtenstein)
- Prior mesh plugs or Prolene Hernia Systems
See the full 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: 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.