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

NCT05484635 | Recruiting

• 1 other identifier: 22-411
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic groin pain; Hernia, Inguinal; Chronic pain groin

Outcome Measures

Primary Outcomes (1)

• 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.

  Change in NRS-11 scores will be measured from baseline to 6 months after surgery for both groups.

Secondary Outcomes (4)

• Visual Analog Scale (VAS)

  Baseline, 3-months and 6-months

• Activities Assessment Scale (AAS)

  Baseline, 3-months and 6-months

• EuroQOL (EQ-5D-5L) questionnaire

  Baseline, 3-months and 6-months

• Numerical Rating Scale (NRS-11)

  Baseline NRS-11 scores will be measured and compared to scores at 3 months after surgery for both groups.

Study Arms (2)

Diagnostic laparoscopy

ACTIVE COMPARATOR

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

Laparoscopic mesh removal

EXPERIMENTAL

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

Interventions

Diagnostic laparoscopy and inguinal mesh removal PROCEDURE

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

Laparoscopic mesh removal

Diagnostic laparoscopy PROCEDURE

Surgical examination through laparoscopy without removal of mesh

Diagnostic laparoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• David Krpata: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• David Krpata, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Krpata, MD

CONTACT

216-445-9989; krpatad@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 2, 2022
• Study Start: July 25, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 6, 2025

Record last verified: 2025-10

Locations

US (1)