Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Minimally Invasive Inguinal Hernia Repair: A Randomized Controlled Trial
David Krpata
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.
Description
This is a double-blinded, parallel (1:1) group, randomized-controlled, superiority trial. Patients will be blinded to their treatment allocation and will understand that by entering the study, they may receive diagnostic laparoscopy only in which case their mesh will not be removed. However, they will be allowed to consider crossing over to the mesh removal group 6 months or later after surgery if they do not have adequate pain relief. Patients will receive written and oral descriptions of the trial and will be provided time to review written documentation in private. Written and oral consent…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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) Somatose…
Interventions
- ProcedureDiagnostic laparoscopy and inguinal mesh removal
Surgical examination and treatment of groin pain following inguinal hernia surgery by surgical exploration with a laparoscope or removal of mesh laparoscopically
- ProcedureDiagnostic laparoscopy
Surgical examination through laparoscopy without removal of mesh
Location
- Cleveland ClinicCleveland, Ohio