Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Minimally Invasive Inguinal Hernia Repair: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ \> 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

Locations
United States
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Contact Information
Primary
David Krpata, MD
krpatad@ccf.org
216-445-9989
Time Frame
Start Date: 2022-07-25
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 70
Treatments
Active_comparator: Diagnostic laparoscopy
Minimally invasive incisions will be made, and a diagnostic laparoscopy will be performed. The surgeon will evaluate the mesh configuration, ensuring proper positioning, perform adhesiolysis if indicated for bowel involvement with the mesh and assess the abdomen for alternative sources of chronic pain.
Experimental: Laparoscopic mesh removal
Minimally invasive incisions will be made, and a diagnostic laparoscopy will be performed. The surgeon will evaluate the mesh configuration, ensuring proper positioning, perform adhesiolysis if indicated for bowel involvement with the mesh and assess the abdomen for alternative sources of chronic pain. If randomized to mesh removal, laparoscopic or robotic preperitoneal mesh removal.
Related Therapeutic Areas
Sponsors
Leads: David Krpata

This content was sourced from clinicaltrials.gov