History of Changes for Study: NCT05484635

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

Latest version (submitted August 23, 2023) on ClinicalTrials.gov

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			July 29, 2022	None (earliest Version on record)
2			August 23, 2023	Arms and Interventions and Study Status

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Study NCT05484635
Submitted Date: July 29, 2022 (v1)

Study Identification


Unique Protocol ID:	22-411
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
Secondary IDs:

Study Status


Record Verification:	July 2022
Overall Status:	Recruiting
Study Start:	July 25, 2022
Primary Completion:	July 1, 2024 [Anticipated]
Study Completion:	January 1, 2025 [Anticipated]

First Submitted:	July 26, 2022
First Submitted that Met QC Criteria:	July 29, 2022
First Posted:	August 2, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	July 29, 2022
Last Update Posted:	August 2, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	David Krpata
Responsible Party:	Sponsor-Investigator Investigator: David Krpata Official Title: Staff Physician Affiliation: The Cleveland Clinic
Collaborators:

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.

Conditions


Conditions:	Chronic Groin Pain Hernia, Inguinal
Keywords:	Chronic groin pain Hernia, Inguinal Chronic pain groin

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Crossover Assignment
Number of Arms:	2
Masking:	Double (Participant, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	70 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

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.

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

Experimental: Laparoscopic mesh removal

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

Outcome Measures


Primary Outcome Measures:
1.	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.
Secondary Outcome Measures:
1.	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).
2.	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.
3.	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.
4.	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.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
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

Contacts/Locations


Central Contact Person:	David Krpata, MD Telephone: 216-445-9989 Email: krpatad@ccf.org
Central Contact Backup:	Adele Costanzo Telephone: 216-445-3851 Email: constana@ccf.org
Study Officials:	David Krpata, MD Principal Investigator The Cleveland Clinic
Locations:	United States, Ohio
	Cleveland Clinic [Recruiting] Cleveland, Ohio, United States, 44195 Contact:Contact: David Krpata, MD 216-445-9989 krpatad@ccf.org

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