Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Inguinal Hernia Repair

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
David Krpata
Study ID
NCT05484635
Status
Recruiting
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Conditions

  • Chronic Groin Pain
  • Hernia, Inguinal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Diagnostic laparoscopy and inguinal mesh removal — PROCEDURE
    Surgical examination and treatment of groin pain following inguinal hernia surgery by surgical exploration with a laparoscope or removal of mesh laparoscopically
  • Diagnostic laparoscopy — PROCEDURE
    Surgical examination through laparoscopy without removal of mesh

Study Details

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.

Key Dates

Start date
Jul 25, 2022
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Jul 1, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Numerical Rating Scale (NRS-11) [ Time Frame: Change in NRS-11 scores will be measured from baseline to 6 months after surgery for both groups. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
David Krpata, MD
[email protected]
2164459989

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By research site
Cleveland Clinic· Cleveland, OH

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