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ID05484635

Comparing Mesh Removal and No Mesh Removal for Long-Term Groin Pain After Minimally Invasive Inguinal Hernia Repair

Led by David Krpata · Updated on 2025-10-06

70

Participants Needed

1

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the management of chronic post-operative inguinal hernia pain that lasts longer than six months after minimally invasive inguinal hernia repair with pre-peritoneal mesh. The study aims to compare the change in chronic nociceptive pain between patients who undergo mesh removal and those who do not. This is a randomized, double-blinded trial designed to assess whether removing the mesh affects pain levels. Participants are randomly assigned to one of two groups. Both groups receive minimally invasive diagnostic laparoscopy where surgeons examine the mesh and perform adhesiolysis if needed. One group undergoes laparoscopic or robotic removal of the mesh, while the other group has the mesh left in place. Patients remain blinded to their group and may choose to switch to mesh removal after six months if their pain does not improve. During the study, participants will have pain and activity assessments at baseline, 3 months, and 6 months after surgery using tools like the Numerical Rating Scale NRS-11, Visual Analog Scale VAS, Activities Assessment Scale AAS, and EuroQOL questionnaire. Researchers will monitor changes in pain scores and quality of life. The study involves follow-up visits to track outcomes and allows withdrawal at any time. Total participation duration covers at least six months post-surgery.

CONDITIONS

Brief Title

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

Research Team

D

David Krpata, MD

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