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Mesh Removal for Chronic Groin Pain from Hernia Surgery

N/A
Recruiting
Led By David Krpata, MD
Research Sponsored by David Krpata
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
CPIP lasting more than 6 months after laparoscopic or robotic inguinal hernia repair with pre-peritoneal mesh
18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline nrs-11 scores will be measured and compared to scores at 3 months after surgery for both groups.
Awards & highlights

Study Summary

This trial is evaluating the management of chronic post-operative inguinal hernia pain. The study will compare the impact of hernia mesh removal after previous minimally invasive inguinal hernia repairs, to no mesh removal.

Who is the study for?
This trial is for adults who've had laparoscopic or robotic inguinal hernia repair with mesh and suffer from moderate to severe chronic groin pain for over 6 months. They should feel pain when moving, sitting, or feeling a 'foreign body sensation' in the groin without signs of neuropathic pain. People with recurrent hernias, previous different mesh repairs, prostatectomy history, mild pain, or large hernias as per EHS classification can't join.Check my eligibility
What is being tested?
The study compares two groups: one undergoing diagnostic laparoscopy only and another having both diagnostic laparoscopy and inguinal mesh removal. It aims to see if removing the mesh reduces chronic post-operative groin pain after minimally invasive hernia repair.See study design
What are the potential side effects?
Potential side effects may include discomfort from the procedure(s), possible infection at incision sites, bleeding risks associated with surgery, and potential complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had pain for over 6 months after my hernia repair surgery.
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I am 18 years old or older.
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I experience moderate to severe pain when I stand up.
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I feel pain when pressure is applied along the groin ligament.
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I experience severe pain when I cross my affected leg over the other.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline nrs-11 scores will be measured and compared to scores at 3 months after surgery for both groups.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline nrs-11 scores will be measured and compared to scores at 3 months after surgery for both groups. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Activities Assessment Scale (AAS)
EuroQOL (EQ-5D-5L) questionnaire
Numerical Rating Scale (NRS-11)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Laparoscopic mesh removalExperimental Treatment1 Intervention
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.
Group II: Diagnostic laparoscopyActive Control2 Interventions
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.

Find a Location

Who is running the clinical trial?

David KrpataLead Sponsor
David Krpata, MDPrincipal InvestigatorThe Cleveland Clinic

Media Library

Diagnostic laparoscopy and inguinal mesh removal (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05484635 — N/A
Inguinal Hernia Research Study Groups: Diagnostic laparoscopy, Laparoscopic mesh removal
Inguinal Hernia Clinical Trial 2023: Diagnostic laparoscopy and inguinal mesh removal Highlights & Side Effects. Trial Name: NCT05484635 — N/A
Diagnostic laparoscopy and inguinal mesh removal (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05484635 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are enrolled in this medical trial?

"Affirmative. Clinicaltrials.gov displays that this trial, which was first disseminated on July 25th 2022, is currently enrolling participants. Approximately 70 individuals need to be recruited from 1 centre for the study's completion."

Answered by AI

Is enrollment to this clinical study still available?

"Affirmative. The information on clinicaltrials.gov verifies that this medical trial, which was published on July 25th 2022, is actively seeking participants. Approximately 70 subjects must be enlisted from a single research facility."

Answered by AI
~9 spots leftby Jul 2024