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

David Krpata

Status: Enrolling

Conditions: Chronic Groin Pain; Hernia, Inguinal

Treatments: Procedure: Diagnostic laparoscopy and inguinal mesh removal; Procedure: Diagnostic laparoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT05484635

22-411

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

70 participants in 2 patient groups

Diagnostic laparoscopy

Active Comparator group

Description:

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.

Treatment:

Procedure: Diagnostic laparoscopy

Laparoscopic mesh removal

Experimental group

Description:

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.

Treatment:

Procedure: Diagnostic laparoscopy and inguinal mesh removal