Comparing mesh removal to no mesh removal for chronic groin pain after hernia repair
Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Minimally Invasive Inguinal Hernia Repair: A Randomized Controlled Trial
This study is testing whether taking out hernia mesh helps people with chronic groin pain feel better compared to not removing the mesh after their hernia repair.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05484635 on ClinicalTrials.gov |
What this trial studies
This study evaluates the management of chronic groin pain following minimally invasive inguinal hernia repair, specifically assessing the effects of hernia mesh removal versus no removal. It is a double-blinded, randomized-controlled trial where participants may undergo diagnostic laparoscopy and could potentially have their mesh removed if they do not achieve adequate pain relief. Patients will be informed about the trial and can withdraw at any time. The study aims to determine if mesh removal leads to significant pain relief in patients suffering from chronic pain lasting more than six months.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with chronic nociceptive groin pain lasting more than six months after inguinal hernia repair.
Not a fit: Patients who do not exhibit characteristics of nociceptive groin pain or have mild pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective pain relief options for patients suffering from chronic groin pain after hernia repair.
How similar studies have performed: Other studies have explored similar interventions, but the specific approach of mesh removal for chronic pain in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: David Krpata, MD — The Cleveland Clinic
- Study coordinator: David Krpata, MD
- Email: krpatad@ccf.org
- Phone: 216-445-9989
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.