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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
Be older than 18 years old
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
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline nrs-11 scores will be measured and compared to scores at 3 months after surgery for both groups.
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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Activities Assessment Scale (AAS)
EuroQOL (EQ-5D-5L) questionnaire
Numerical Rating Scale (NRS-11)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
David KrpataLead Sponsor
David Krpata, MDPrincipal InvestigatorThe Cleveland Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My hernia is large and located in the groin area, as classified by the EHS.I had open surgery for an inguinal hernia before.My pain does not feel sharp, burning, or increase with touch.I feel like something is in my groin or it feels tight.I experience pain when sitting for long but feel better when I stretch my leg or lie down.I have had pain for over 6 months after my hernia repair surgery.I am 18 years old or older.I do not have a specific point where my pain becomes unbearable.I experience moderate to severe pain when I stand up.I experience pain when sitting for long but feel better when I stretch my leg or lie down.I experience little to no pain when standing up.I feel pain when pressure is applied along the groin ligament.My groin hernia has come back, as confirmed by a doctor.I have had surgery on my prostate or blood vessels in my pelvis or groin.I experience severe pain when I cross my affected leg over the other.I am older than 18 years.I experience severe pain when I cross my affected leg over the other.I feel like something is in my groin or it feels tight.I feel pain when pressing along the groin ligament area.I have had pain for over 6 months after my hernia repair surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic laparoscopy
- Group 2: Laparoscopic mesh removal
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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