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

Primary Purpose

Chronic Groin Pain, Hernia, Inguinal

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diagnostic laparoscopy and inguinal mesh removal
Diagnostic laparoscopy
Sponsored by
David Krpata
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Groin Pain focused on measuring Chronic groin pain, Hernia, Inguinal, Chronic pain groin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Diagnostic laparoscopy

Laparoscopic mesh removal

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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.

Full Information

First Posted
July 26, 2022
Last Updated
August 23, 2023
Sponsor
David Krpata
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1. Study Identification

Unique Protocol Identification Number
NCT05484635
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Krpata

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Groin Pain, Hernia, Inguinal
Keywords
Chronic groin pain, Hernia, Inguinal, Chronic pain groin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic laparoscopy
Arm Type
Active Comparator
Arm 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.
Arm Title
Laparoscopic mesh removal
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Diagnostic laparoscopy and inguinal mesh removal
Intervention Description
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
Intervention Name(s)
Diagnostic laparoscopy
Intervention Description
Surgical examination through laparoscopy without removal of mesh
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS-11)
Description
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.
Time Frame
Change in NRS-11 scores will be measured from baseline to 6 months after surgery for both groups.
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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).
Time Frame
Baseline, 3-months and 6-months
Title
Activities Assessment Scale (AAS)
Description
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.
Time Frame
Baseline, 3-months and 6-months
Title
EuroQOL (EQ-5D-5L) questionnaire
Description
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.
Time Frame
Baseline, 3-months and 6-months
Title
Numerical Rating Scale (NRS-11)
Description
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.
Time Frame
Baseline NRS-11 scores will be measured and compared to scores at 3 months after surgery for both groups.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Krpata, MD
Phone
216-445-9989
Email
krpatad@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
Adele Costanzo
Phone
216-445-3851
Email
constana@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Krpata, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Krpata, MD
Phone
216-445-9989
Email
krpatad@ccf.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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