What this study is
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.
What's being tested
- Diagnostic laparoscopy and inguinal mesh removal
Intervention · 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
Intervention · PROCEDURE
Surgical examination through laparoscopy without removal of mesh
Study details
- Official title
- Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Minimally Invasive Inguinal Hernia Repair: A Randomized Controlled Trial
- Sponsor
- David Krpata
- Conditions
- Chronic Groin Pain · Hernia, Inguinal
- Enrolling
- 70 people
- Starts
- 2022-07-25
- Est. completion
- 2028-07-01
- Design
- Double-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- > 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) Somatosensory mapping:; Does not have a maximum trigger point for pain; Lacks characteristics of neuropathic pain (sharp, burning, shooting, paresthesias, allodynia, hyperalgesia, etc.); Moderate to severe pain [4-10] when moving from supine to standing on NRS
You can't join if
- No characteristics of nociceptive groin pain
- Zero or mild pain [0-3] when moving from supine to standing on NRS
- Recurrent inguinal hernia detected on clinical exam
- Large, femoral, direct or indirect inguinal hernia (F2-3, M2-3, L2-3) on diagnostic laparoscopy as defined by European Hernia Society (EHS) classification
- Prior open (anterior) approach to inguinal hernia repair (i.e. Lichtenstein)
- Prior mesh plugs or Prolene Hernia Systems
- History of prostatectomy or vascular procedures in the pelvis or groin
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 open- Recruiting
Study team
Sponsor
David Krpata
Study ID 22-411
Principal investigator
David Krpata, MD
The Cleveland Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.