Recruiting

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

Sponsor:

David Krpata

Code:

NCT05484635

Conditions

Chronic Groin Pain

Hernia, Inguinal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Diagnostic laparoscopy and inguinal mesh removal

Diagnostic laparoscopy

Study Details

Brief 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.

Conditions

Chronic Groin Pain

Hernia, Inguinal

Study ID

NCT05484635

Start date

Jul 25, 2022

Status verified date

Oct, 2025

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

> 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

Exclusion Criteria:

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: Laparoscopic mesh removal

Interventions

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

Diagnostic laparoscopy

Surgical examination through laparoscopy without removal of mesh

Primary outcome measure

Numerical Rating Scale (NRS-11) [ Time Frame: Change in NRS-11 scores will be measured from baseline to 6 months after surgery for both groups. ]

Central Contacts and Locations

Central contacts

David Krpata, MD

216-445-9989 krpatad@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

David Krpata, MD

2164459989 krpatad@ccf.org

More Information

Sponsor

David Krpata

Last update posted

Oct 6, 2025

Last verified

Oct, 2025

Keywords

Chronic groin pain
Hernia, Inguinal
Chronic pain groin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by David Krpata on 2025-10-06.