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

• ClinicalTrials.gov Identifier: NCT05484635
• Recruitment Status: Recruiting
• First Posted: August 2, 2022
• Last Update Posted: August 25, 2023
• Sponsor: David Krpata
• Information provided by (Responsible Party): David Krpata, The Cleveland Clinic

Tracking Information

• First Submitted Date: July 26, 2022
• First Posted Date: August 2, 2022
• Last Update Posted Date: August 25, 2023
• Actual Study Start Date: July 25, 2022
• Estimated Primary Completion Date: July 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 29, 2022)

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. ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 29, 2022)

• Visual Analog Scale (VAS) [ Time Frame: Baseline, 3-months and 6-months ]
  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).
• Activities Assessment Scale (AAS) [ Time Frame: Baseline, 3-months and 6-months ]
  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.
• EuroQOL (EQ-5D-5L) questionnaire [ Time Frame: Baseline, 3-months and 6-months ]
  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.
• Numerical Rating Scale (NRS-11) [ Time Frame: Baseline NRS-11 scores will be measured and compared to scores at 3 months after surgery for both groups. ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Inguinal Hernia Repair
• Official Title: Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Minimally Invasive Inguinal Hernia Repair: A Randomized Controlled Trial

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Chronic Groin Pain
• Hernia, Inguinal

Intervention

• 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
• Procedure: Diagnostic laparoscopy
  Surgical examination through laparoscopy without removal of mesh

Study 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.
  Intervention: Procedure: Diagnostic laparoscopy
• Experimental: 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.
  Intervention: Procedure: Diagnostic laparoscopy and inguinal mesh removal

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 29, 2022): 70
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 1, 2025
• Estimated Primary Completion Date: July 1, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: David Krpata, MD; 216-445-9989; krpatad@ccf.org

Contact: Adele Costanzo; 216-445-3851; constana@ccf.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05484635
• Other Study ID Numbers: 22-411
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: David Krpata, The Cleveland Clinic
• Original Responsible Party: Same as current
• Current Study Sponsor: David Krpata
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: David Krpata, MD; The Cleveland Clinic

• PRS Account: The Cleveland Clinic
• Verification Date: August 2023