Actively Recruiting
Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Minimally Invasive Inguinal Hernia Repair: A Randomized Controlled Trial
Led by David Krpata · Updated on 2025-10-06
70
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years of age
- Chronic post-operative inguinal pain lasting more than 6 months after laparoscopic or robotic inguinal hernia repair with pre-peritoneal mesh
- Presence of one or more nociceptive pain characteristics including pain when sitting with relief on hip extension or lying down, severe pain when crossing the affected leg over the other, or a foreign body sensation or tightness in the groin
- Diffuse tenderness on deep palpation along the inguinal ligament over the mesh
- Pain rated moderate to severe (4-10) on Numerical Rating Scale (NRS) when moving from lying down to standing
- No evidence of neuropathic pain features such as sharp, burning, shooting pain or numbness
You will not qualify if you...
- No nociceptive groin pain characteristics
- Zero or mild pain (0-3) on NRS when moving from lying down to standing
- Recurrent inguinal hernia detected on clinical exam
- Large femoral, direct, or indirect inguinal hernia classified as F2-3, M2-3, or L2-3 on laparoscopy
- Prior open (anterior) inguinal hernia repair such as Lichtenstein
- Prior mesh plugs or Prolene Hernia Systems used
- History of prostatectomy or vascular surgery in the pelvis or groin area
- Unable or unwilling to consent or participate voluntarily
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus immediate recovery period
Participants undergo minimally invasive surgery either with diagnostic laparoscopy alone or with laparoscopic mesh removal to treat chronic groin pain after hernia repair.
1 surgical visit (in-person)
Duration - 6 months
Participants are monitored for pain relief and recovery after surgery, with assessments to determine if additional treatment is needed.
Visits at baseline, 3 months, and 6 months
Duration - After 6 months from initial surgery, timing varies
Participants without adequate pain relief after 6 months may choose to cross over to the mesh removal surgery group.
Additional visits as needed based on crossover decision
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
D
David Krpata, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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