Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Inguinal Hernia Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid Krpata
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
> 18 years of age
CPIP lasting > 6 months after laparoscopic or robotic inguinal hernia repair with pre-peritoneal mesh
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Diagnostic laparoscopy and inguinal mesh removal
Procedure/SurgerySurgical examination and treatment of groin pain following inguinal hernia surgery by surgical exploration with a laparoscope or removal of mesh laparoscopically
Diagnostic laparoscopy
Procedure/SurgerySurgical examination through laparoscopy without removal of mesh
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Diagnostic laparoscopyActive comparator 1 intervention
Group B: Laparoscopic mesh removalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Numerical Rating Scale (NRS-11)
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.
Time frame
Change in NRS-11 scores will be measured from baseline to 6 months after surgery for both groups.Secondary outcomes
1
Visual Analog Scale (VAS)
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).
Time frame
Baseline, 3-months and 6-months2
Activities Assessment Scale (AAS)
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.
Time frame
Baseline, 3-months and 6-months3
EuroQOL (EQ-5D-5L) questionnaire
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.
Time frame
Baseline, 3-months and 6-months4
Numerical Rating Scale (NRS-11)
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.
Time frame
Baseline NRS-11 scores will be measured and compared to scores at 3 months after surgery for both groups.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
David Krpata
Lead sponsor
The Cleveland Clinic
Sponsor institution
Source ClinicalTrials.gov