NCT05484635

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: David Krpata · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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 will be obtained, and patients will understand that their participation is voluntary and refusal to participate will not affect future medical care. Patients may also withdraw from the trial at any point throughout the study period. The Cleveland Clinic Center for Abdominal Core Health, a center within the Digestive Disease and Surgery Institute (DDSI), at Cleveland Clinic Foundation Main Campus in Cleveland, Ohio is the hosting department for this study. Cleveland Clinic - Hillcrest Hospital in Mayfield Heights, Ohio will also be a participating center in this study. Fellowship-trained surgeons with expertise in complex abdominal wall reconstruction and mesh removal will perform the operations. If enrollment fails to meet necessary accrual size within the study timeframe, additional centers may be invited to participate.

Conditions

• Chronic Groin Pain
• Hernia, Inguinal

Interventions

Type	Name	Description
PROCEDURE	Diagnostic 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
PROCEDURE	Diagnostic laparoscopy	Surgical examination through laparoscopy without removal of mesh

Timeline

• Start date: 2022-07-25
• Primary completion: 2027-12-31
• Completion: 2028-07-01
• First posted: 2022-08-02
• Last updated: 2025-10-06

Locations

1 site across 1 country: United States