Mesh Removal for Chronic Groin Pain from Hernia Surgery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: David Krpata
Disqualifiers: Recurrent hernia, Large hernia, Prior open repair, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment for mesh removal in chronic groin pain after hernia surgery?
Research shows that removing the mesh can help reduce chronic pain in some patients who have had hernia surgery. Studies indicate that laparoscopic (a minimally invasive surgery using small incisions) mesh removal is safe and may be effective for those with persistent pain after hernia repair.
12345Is mesh removal surgery for chronic groin pain after hernia repair safe?
Research indicates that laparoscopic mesh removal for chronic groin pain after hernia surgery is generally considered safe, with studies showing it is feasible and without serious complications in selected patients.
26789How is the treatment of mesh removal for chronic groin pain after hernia surgery different from other treatments?
Mesh removal for chronic groin pain after hernia surgery is unique because it involves a laparoscopic procedure (a minimally invasive surgery using small incisions and a camera) to remove the mesh that may be causing pain, whereas other treatments might focus on managing pain without removing the mesh. This approach is considered when other treatments have failed and is seen as a feasible and potentially effective option for selected patients.
123910Eligibility Criteria
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.Inclusion Criteria
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.
+7 more
Exclusion 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.
Prior mesh plugs or Prolene Hernia Systems
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo either diagnostic laparoscopy or laparoscopic mesh removal
Immediate (surgical procedure)
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
3 visits (in-person)
Optional Crossover
Participants may opt to crossover to the mesh removal group if inadequate pain relief is experienced
6 months or later
Participant Groups
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.
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.
Diagnostic laparoscopy and inguinal mesh removal is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Diagnostic Laparoscopy and Inguinal Mesh Removal for:
- Chronic post-operative inguinal hernia pain
🇪🇺 Approved in European Union as Diagnostic Laparoscopy and Inguinal Mesh Removal for:
- Chronic post-operative inguinal hernia pain
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland ClinicCleveland, OH
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Who Is Running the Clinical Trial?
David KrpataLead Sponsor
References
Factors Determining Outcome After Surgery for Chronic Groin Pain Following a Lichtenstein Hernia Repair. [2018]Some patients develop chronic groin pain after a Lichtenstein hernia repair. Previous studies have demonstrated beneficial effects of removal of entrapped inguinal nerves or a meshectomy in patients with chronic pain after open inguinal hernia mesh repair. Factors determining success following this remedial surgery are unknown. The aim of the study was to identify potential patient- or surgery-related factors predicting the surgical efficacy for inguinodynia following Lichtenstein repair.
Laparoscopic mesh removal for otherwise intractable inguinal pain following endoscopic hernia repair is feasible, safe and may be effective in selected patients. [2019]Laparoscopic inguinal hernia repair is preferred over an open technique because of reduced recovery time, favorable cost effectiveness, and less chronic postoperative inguinal pain. Nevertheless, some patients develop a nociceptive inguinal pain syndrome possibly related to the presence of the mesh. This is the first study describing feasibility, safety, and effectiveness of laparoscopic mesh removal in patients with chronic pain after endoscopic hernia repair.
Laparoscopic mesh removal for chronic postoperative inguinal pain following endoscopic hernia repair: a cohort study on the effect on pain. [2023]Chronic postoperative inguinal pain (CPIP) after pre-peritoneal hernia repair is rare but may be severely invalidating. Mesh may be a contributing factor to the development of CPIP. International guidelines acknowledge mesh removal as a treatment option for CPIP after open repair, but experience in laparoscopic mesh removal is limited. Surgeons are hesitant to remove pre-peritoneal meshes because of fear of operative complications. This observational study describes risks and effectiveness of laparoscopic mesh removal in patients with CPIP after endoscopic inguinal hernia repair.
An international consensus algorithm for management of chronic postoperative inguinal pain. [2021]Tension-free mesh repair of inguinal hernia has led to uniformly low recurrence rates. Morbidity associated with this operation is mainly related to chronic pain. No consensus guidelines exist for the management of this condition. The goal of this study is to design an expert-based algorithm for diagnostic and therapeutic management of chronic inguinal postoperative pain (CPIP).
Combined open and laparoscopic approach to chronic pain following open inguinal hernia repair. [2018]Chronic groin pain is the most common long-term complication after open inguinal hernia repair. Traditional surgical management of the associated neuralgia consists of injection therapy followed by groin exploration, mesh removal, and nerve transection. The resultant hernia defect may be difficult to repair from an anterior approach. We evaluate the outcomes of a combined laparoscopic and open approach for the treatment of chronic groin pain following open inguinal herniorrhaphy.
Chronic pain after mesh repair of inguinal hernia: a systematic review. [2022]Chronic pain is a severe complication of mesh-based inguinal hernia repair. Its perceived risk varies widely in the literature. The current objectives are to review the incidence, severity, and consequences of chronic pain and its etiologies.
Herniography in 79 patients with unexplained pain in the groin: a retrospective study. [2019]To assess the safety and accuracy of herniography for the diagnosis of inguinal hernia in young military men with unexplained pain in the groin, a retrospective study in 79 patients with unexplained pain in the groin who underwent a herniography is presented. Nineteen patients (24%) showed a positive herniogram which was confirmed in 15 out of 16 patients who subsequently underwent surgery. All 60 (76%) patients with a negative herniography were followed-up. An inguinal hernia was subsequently found at surgery in two patients out of eight who were operated on later. In our series no serious complications occurred. Herniography has been shown to be a safe and reliable method to demonstrate or exclude an inguinal hernia in young military men with unexplained pain in the groin. The differential diagnosis in this specific patient group is discussed.
The Lichtenstein repair. [2015]The description of the Lichtenstein tension-free mesh repair 12 years ago opened a new era in groin hernia repair. Without the risk for severe morbidity, it can be readily carried out on patients previously considered unsuitable for hernia repair. Fears of complications related to mesh implantation have proved to be without foundation. As a local anesthetic outpatient procedure without the need for complex and expensive instrumentation, combined with the ability of patients to return to work in a short time, overall costs can be kept to a minimum without in any way compromising the safety or the long-term success of the procedure.
[Diagnostics and therapy of chronic pain following hernia operation]. [2022]The frequency of chronic pain after hernia repair is currently much higher than the recurrence rate. For inguinal hernias it has been shown that mesh-based techniques are comparable to mesh-free techniques concerning chronic pain. Risk factors could be clearly identified for inguinal hernia repair and include open repair, meshes with small pores, mesh fixation with sutures or tacks, pre-existing pain and severe pain during the early postoperative period. The last two risk factors are also important for incisional hernias. For laparoscopic incisional hernia repair, the width (> 10 cm) of the gap seems to correlate with chronic pain. The diagnostic measures are restricted to the identification of a segmental problem in terms of nerve entrapment which can be blocked by local anesthesia or definite neurectomy. In some cases of chronic pain after inguinal hernia repair removal of the mesh will be advisable. After incisional hernia repair a segmental involvement is rarely seen. Localized pain may be induced by stay sutures which can be removed. Mesh removal is, however, a complex procedure especially after open repair resulting in hernia recurrence and therefore represents a salvage technique. The prophylaxis of chronic pain is therefore of utmost importance as is the identification of patients at risk which is now possible. These patients for example with inguinal hernias should be treated laparoscopically with an adequate technique including meshes with big pores and without fixation or fixation with glue only.
Randomized comparison of self-fixating and sutured mesh in open inguinal hernia repair. [2012]Chronic groin pain after mesh repair of inguinal hernia has been attributed to the presence of sutures.