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

NCT ID: NCT05484635

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-25
• Study Completion Date: 2028-07-01

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.

Detailed 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.

Conditions

Chronic Groin Pain; Hernia, Inguinal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Diagnostic laparoscopy

Intervention Type: PROCEDURE

Surgical examination through laparoscopy without removal of mesh

Laparoscopic mesh removal

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.

Group Type: EXPERIMENTAL

Diagnostic laparoscopy and inguinal mesh removal

Intervention Type: PROCEDURE

Surgical examination and treatment of groin pain following inguinal hernia surgery by surgical exploration with a laparoscope or removal of mesh laparoscopically

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

Intervention Type: PROCEDURE

Diagnostic laparoscopy

Surgical examination through laparoscopy without removal of mesh

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

David Krpata

OTHER

Sponsor Role: lead

Responsible Party

David Krpata

Staff Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David Krpata, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Krpata, MD

Role: CONTACT

krpatad@ccf.org

216-445-9989

Facility Contacts

David Krpata, MD

Role: primary

krpatad@ccf.org

2164459989

Other Identifiers

22-411

Identifier Type: -

Identifier Source: org_study_id