Study Comparing Total Extraperitoneal Patch TEP Versus Lichtenstein According Chronic Pain

Study Overview
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Brief Summary
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The purpose of this study is to se if there is a difference regarding chronic pain and sexual dysfunction one and tree years after laparoscopic un fixated preperitoneal mesh versus gold standard open fixated on lay mesh in inguinal hernia surgery. Long term cross-sectional follow-up comparing different instruments for measurement of chronic pain.

Detailed Description
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Prospective randomized study comparing total extraperitoneal patch TEP versus open onlay mesh according to Lichtenstein in primary unilateral inguinal hernias in men between 30 to 75 years of age. Non fixated polypropylene mesh is used in the TEP operation and fixated light weight polypropylene mesh is used in the Lichtenstein procedure. The aim is to study chronical pain and sexual dysfunction. Clinical examination according nerve function, hernia status and genital findings are performed together with a questionnaire including SF36, Inguinal Pain Questionnaire(IPQ), sexual function are registered preoperatively, one and tree years postoperatively. Cross-sectional follow-up in median 7.5 years using enquiries for comparison of different pain instruments to evaluate the effect of chronic pain on physical activity.

Official Title
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A Randomised Controlled Trial Comparing Total Extra-Peritoneal (TEP) to Lichtenstein Inguinal Hernia Repair Concerning Physical Sequelae and Quality of Life at One and Three Years - the TEPLICH Trial

Conditions
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Chronic Pain, Sexual Dysfunction

Intervention / Treatment
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* Procedure: Total Extraperitoneal repair (TEP)
* Procedure: Lichtenstein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men between 30-75 years of age ASA class I-II primary unilateral inguinal hernia Exclusion Criteria: lower midline incision below linea arcuate large scrotal hernia previously or current abuse,mental disease obesity BMI > 35 another simultaneous operation nonreducible hernia severe pain in the groin without nonrelated to hernia contraindications to general anesthesia need of language translator liver cirrhosis or ascites spread cancer disease previously irradiation in the area lack of operations indication

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lichtenstein<br>Open operation with onlay light weight polypropylene mesh | Procedure: Total Extraperitoneal repair (TEP)<br>* Operation for primary inguinal hernias i men<br>* Other names: Hernia mesh operation;|
| Active Comparator: Total Extraperitoneal repair (TEP)<br>Laparoscopic operation with preperitoneal nonfixated mesh | Procedure: Lichtenstein<br>* Operation for primary inguinal hernias i men<br>* Other names: Anterior mesh repair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic pain during the last week (IPQ2) 1 year postoperatively measured using question 2 of the Inguinal Pain Questionnaire (IPQ). | The worst pain last week one year postoperatively. Measured using question 2 of IPQ-questionaire with the cutoff for pain set between grade 2 (pain present but could easily be ignored) and grade 3 (pain present but does not interfere with everyday activities) | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measured using the SF-36 questionnaire | SF-36 is composed of eight sub-scales and the composite scores for physical and mental health. Norm-based scores were calculated using the Swedish age and gender specific means and standard deviations. The norm data have a mean of 50 and a standard deviation (SD) of 10. A 5-point difference corresponds to an effect size (Cohen's d) of 0.5 SD, which was regarded as a medium-sized clinical difference. | one and three years | 
| Chronic pain right now and during the last week (IPQ1 and IPQ2) measured using question 1 and 2 of the inguinal pain questionnaire. | Chronic pain was measured using IPQ with the following cutoffs. Any pain last week (IPQ2 grade 2-7) and any pain right now (IPQ2 grade 2-7) at 1 and 3 years. Pain right now (IPQ1 grade 3-7) at 1 and 3 years and pain last week (IPQ2 grade 3-7) at 3 years | IPQ1 grade 2-7, IPQ1 grade 3-7 and IPQ2 grade 2-7 measured at one and three years. IPQ2 grad 3-7 measured at three years. | 
| Clinical exam assessing groin complaints | Clinical examination was performed assessing groin complaints were reported in six dimensions (no complaints, tenderness, decreased sensation to touch, decreased sensation to pricking, increased sensation to touch or pricking, radiation of pain) in five defined locations in the groin/scrotum area. | Exams were performed preoperatively, at one and three years | 
| A newly developed SexIHS questionnaire designed to specifically address sexual dysfunction associated with a diagnosed inguinal hernia or following inguinal hernia surgery. | The first 2 questions adressing whether the patient is sexually active and if they have pain during intercourse. The following questions address pain-related sexual dysfunction by describing pain frequency, pain intensity, erectile or ejaculatory dysfunction and symptoms of depression. Two additional questions aimed to describe localisation and type of pain. Scores in the questionnaire vary between 0-12. | Mean 33 months after surgery | 
| Physical function score measuring the ability to perform common daily activities | Physical function was measured using a functional score that was created by assessing three daily activities. Climbing stairs, squatting and raising from bed Each activity was graded from 0-2 points (0 = no discomfort, 1 = mild/moderate discomfort, and 2 = severe discomfort in need of support) with a sum of all scores between 0-6. | The functional score was measured preoperatively, at one and three years | 
| Number of patients with a recurrence after TEP and Lichtenstein surgery | Recurrence after TEP and Lichtenstein repair. | After one and three years | 
| Number patients with a harmful event during surgery after TEP and Lichtenstein | A harmful event was defined as an unplanned chronic inconvenient condition beyond therapy following surgery (e.g. testicular atrophy or pain that did not exist before operation). | After one and three years | 
| Number of patients with a adverse events after TEP and Lichtenstein surgery | An adverse event was defined as either a reoperation due to a postoperative complication within 3 years or severe pain defined as IPQ2 grade 5-7 | After one and three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inguinal hernia, TEP, Lichtenstein, Mesh, Randomized, Chronic pain, Sexual dysfunction