Diagnostic laparoscopy and inguinal mesh removal for Inguinal region

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cleveland Clinic, Cleveland, OH
Inguinal region+2 More
Diagnostic laparoscopy and inguinal mesh removal - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Inguinal region
  • Hernia, Inguinal

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

0 Primary · 4 Secondary · Reporting Duration: Baseline NRS-11 scores will be measured and compared to scores at 3 months after surgery for both groups.

Month 3
Numerical Rating Scale (NRS-11)
Baseline, 3-months and 6-months
Activities Assessment Scale (AAS)
EuroQOL (EQ-5D-5L) questionnaire
Visual Analog Scale (VAS)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Diagnostic laparoscopy
1 of 2
Laparoscopic mesh removal
1 of 2
Active Control
Experimental Treatment

70 Total Participants · 2 Treatment Groups

Primary Treatment: Diagnostic laparoscopy and inguinal mesh removal · No Placebo Group · N/A

Laparoscopic mesh removal
Procedure
Experimental Group · 1 Intervention: Diagnostic laparoscopy and inguinal mesh removal · Intervention Types: Procedure
Diagnostic laparoscopy
Procedure
ActiveComparator Group · 1 Intervention: Diagnostic laparoscopy and inguinal mesh removal · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline nrs-11 scores will be measured and compared to scores at 3 months after surgery for both groups.
Closest Location: Cleveland Clinic · Cleveland, OH
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2004First Recorded Clinical Trial
0 TrialsResearching Inguinal region
971 CompletedClinical Trials

Who is running the clinical trial?

David KrpataLead Sponsor
David Krpata, MDPrincipal InvestigatorThe Cleveland Clinic

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have severe pain when crossing the affected leg over the contralateral leg.
-Deep tenderness with deep palpation along the inguinal ligament (over the mesh).
You have no characteristics of neuropathic pain.
You have moderate to severe pain when moving from supine to standing on the Numeric Rating Scale.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.