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

Hernia, Inguinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05484635
• Other study ID #: 22-411
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: August 2023
• Source: The Cleveland Clinic
• Contact: David Krpata, MD
• Phone: 216-445-9989
• Email: krpatad[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Groin Pain
• Hernia
• 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
• Diagnostic laparoscopy
Surgical examination through laparoscopy without removal of mesh

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
David Krpata

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analog Scale (VAS)	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).	Baseline, 3-months and 6-months
Secondary	Activities Assessment Scale (AAS)	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.	Baseline, 3-months and 6-months
Secondary	EuroQOL (EQ-5D-5L) questionnaire	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.	Baseline, 3-months and 6-months
Secondary	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.	Baseline NRS-11 scores will be measured and compared to scores at 3 months after surgery for both groups.