An interventional study of Diagnostic laparoscopy and inguinal mesh removal and Diagnostic laparoscopy in Chronic Groin Pain and Hernia, Inguinal, sponsored by David Krpata. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by David Krpata · Not applicable, Interventional, and Treatment
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.
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.
549 studies on the registry are indexed under Hernia, Inguinal; 74 are open to participants now.
This study's planned enrollment of 70 is below the median of 90 across 406 interventional studies indexed under Hernia, Inguinal.
Browse Hernia, Inguinal studies →David Krpata is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
History:
Exam:
-Diffuse tenderness with deep palpation along the inguinal ligament (over the mesh)
Somatosensory mapping:
Lacks characteristics of neuropathic pain (sharp, burning, shooting, paresthesias, allodynia, hyperalgesia, etc.)
Exclusion Criteria:
Minimally invasive incisions will be made, and a diagnostic laparoscopy will be performed. The surgeon will evaluate the mesh configuration, ensuring proper positioning, perform adhesiolysis if indicated for bowel involvement with the mesh and assess the abdomen for alternative sources of chronic pain.
Procedure: Diagnostic laparoscopy
Minimally invasive incisions will be made, and a diagnostic laparoscopy will be performed. The surgeon will evaluate the mesh configuration, ensuring proper positioning, perform adhesiolysis if indicated for bowel involvement with the mesh and assess the abdomen for alternative sources of chronic pain. If randomized to mesh removal, laparoscopic or robotic preperitoneal mesh removal.
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
Surgical examination through laparoscopy without removal of mesh
Numerical Rating Scale (NRS-11)
NRS-11 is a validated, 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) and is commonly used to measure Chronic Post-operative Inguinal Pain (CPIP). NRS-11 categorizes pain as none \[0\], mild \[1-3\], moderate \[4-6\], and severe \[7-10\]. Patients will be asked to select the single number that best represents their groin pain intensity when moving from a supine to standing position.
Time frame: Change in NRS-11 scores will be measured from baseline to 6 months after surgery for both groups.
Visual Analog Scale (VAS)
VAS is validated and consists of a 100 mm horizontal line anchored by two descriptors indicating the extremes: 0 (no pain) and 100 (worst pain imaginable).
Time frame: Baseline, 3-months and 6-months
Activities Assessment Scale (AAS)
AAS is a 13-item, validated tool measuring physical impairment due to chronic groin pain. AAS scores are converted to a range of 0-100, with higher values indicating better functional ability.
Time frame: Baseline, 3-months and 6-months
EuroQOL (EQ-5D-5L) questionnaire
EQ-5D-5L is a validated tool evaluating 5 dimensions of health using 5 severity descriptors and includes a visual analog scale labeled from 0 to 100 to quantitatively measure overall health status. The larger the number the better the outcome.
Time frame: Baseline, 3-months and 6-months
Numerical Rating Scale (NRS-11)
NRS-11 is a validated, 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) and is commonly used to measure Chronic Post-operative Inguinal Pain (CPIP). NRS-11 categorizes pain as none \[0\], mild \[1-3\], moderate \[4-6\], and severe \[7-10\]. Patients will be asked to select the single number that best represents their groin pain intensity when moving from a supine to standing position.
Time frame: Baseline NRS-11 scores will be measured and compared to scores at 3 months after surgery for both groups.
Plan to share: Undecided
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David Krpata