Inguinal Hernia Repair and Male Fertility

Study Overview
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Brief Summary
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General objective: To evaluate the fertility of adult men submitted to bilateral herniorrhaphy with mesh placement by the Lichtenstein and laparoscopic approaches

Detailed Description
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Specific objectives: To correlate pre and postoperative data (90 and 180 days) of adult men, according to biochemistry parameters (hemogram and CRP), autoimmune (anti-sperm antibodies), hormonal (FSH, LH and testosterone), perfusion and volume testicular (USG of testicles with Doppler), spermogram, sexual changes, pain and quality of life (standard questionnaires).

Official Title
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Bilateral Inguinal Hernia Repair and Male Fertility: A Randomized Clinical Trial Comparing Lichtenstein Versus Laparoscopic Transabdominal Preperitoneal (TAPP) Technique

Conditions
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Inguinal Hernia Bilateral

Intervention / Treatment
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* Procedure: Bilateral hernioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Age between 19 and 60 years old Bilateral inguinal hernia Primary and reducible inguinal hernia Exclusion Criteria: Age less than 19 or more than 60 years old ASA >III Genito-urinary infection Immunodeficiency History of testicular trauma2 History of surgery or pelvic radiotherapy History of testicular disease Fertility problems or sexual Illness that can be infertile Recurrent hernia Unilateral hernia Femoral or inguine-scrotal hernia Imprisoned hernia Use of Gonadotrophins Use of anabolic steroids

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Randomized clinical trial with two groups, in according to hernioplasty correction approach
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lichtenstein<br>Conventional approach | Procedure: Bilateral hernioplasty<br> <br> |
| Experimental: Laparoscopy<br>Experimental approach | Procedure: Bilateral hernioplasty<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm Volume | Sperm Volume (in ml) measured by Semen analysis | Preoperative | 
| Sperm concentration | Sperm concentration (million sperm/ml) measured by Semen analysis | Preoperative | 
| Sperm number | Sperm number in million measured by Semen analysis | Preoperative | 
| Sperm motility | Sperm motility in % of progression measured by Semen analysis | Preoperative | 
| Sperm morphology | Sperm morphology, according to the Kruger classification, evaluated by Semen analysis | Preoperative | 
| Testicular volume | Testicular volume, in cm3, measured by testicular ultrasound | Preoperative | 
| Testicular vascularization | Testicular vascularization, normal or not, measured by testicular Doppler ultrasound | Preoperative | 
| Sperm Volume | Sperm Volume (in ml) measured by Semen analysis | 90th postoperative day | 
| Sperm concentration | Sperm concentration (million sperm/ml) measured by Semen analysis | 90th postoperative day | 
| Sperm number | Sperm number in million measured by Semen analysis | 90th postoperative day | 
| Sperm motility | Sperm motility in % of progression measured by Semen analysis | 90th postoperative day | 
| Sperm morphology | Sperm morphology, according to the Kruger classification, evaluated by Semen analysis | 90th postoperative day | 
| Testicular volume | Testicular volume, in cm3, measured by testicular ultrasound | 90th postoperative day | 
| Testicular vascularization | Testicular vascularization, normal or not, measured by testicular Doppler ultrasound | 90th postoperative day | 
| Sperm Volume | Sperm Volume (in ml) measured by Semen analysis | 180th postoperative day | 
| Sperm concentration | Sperm concentration (million sperm/ml) measured by Semen analysis | 180th postoperative day | 
| Sperm number | Sperm number in million measured by Semen analysis | 180th postoperative day | 
| Sperm motility | Sperm motility in % of progression measured by Semen analysis | 180th postoperative day | 
| Sperm morphology | Sperm morphology, according to the Kruger classification, evaluated by Semen analysis | 180th postoperative day | 
| Semen analysis | Volume (ml), Concentration (million/ml), Sperm number (million), Motility (% of progression), Morphology (Kruger classification) | 180th postoperative day | 
| Testicular volume | Testicular volume, in cm3, measured by testicular ultrasound | 180th postoperative day | 
| Testicular vascularization | Testicular vascularization, normal or not, measured by testicular Doppler ultrasound | 180th postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follicle Stimulating Hormone (FSH) dosage | Serum FSH (IU/L) | Preoperative | 
| Luteinizing Hormone (LH) dosage | Serum LH (IU/L) | Preoperative | 
| Testosterone Hormone dosage | Serum Testosterone (ng/dl) | Preoperative | 
| Sex hormone-binding globulin (SHGB) dosage | Serum SHGB (nmol/L) | Preoperative | 
| Sexual activity | Satisfied or not with sexual performance, Changes in arousal, Changes in libido and Changes in ejaculation or orgasm (Specific questionnaires) | Preoperative | 
| Quality-of-life evaluation (SF-36 questionnaire) | SF36 Domains: Role physical, Physical function, Role emotional, Energy, Emotional health, Social functioning, Bodily pain and General health. Scale ranging from 0 to 100, where zero is the worst state and 100 is the best. | Preoperative | 
| Postoperative pain | Visual Analog Scale (VAS) score ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain | 7th postoperative day | 
| Postoperative pain | Visual Analog Scale (VAS) score ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain | 30th postoperative day | 
| Follicle Stimulating Hormone (FSH) dosage | Serum FSH (IU/L) | 90th postoperative day | 
| Luteinizing Hormone (LH) dosage | Serum LH (IU/L) | 90th postoperative day | 
| Testosterone Hormone dosage | Testosterone (ng/dl) | 90th postoperative day | 
| Sex hormone-binding globulin (SHGB) dosage | Serum SHGB (nmol/L) | 90th postoperative day | 
| Sexual activity | Satisfied or not with sexual performance, Changes in arousal, Changes in libido and Changes in ejaculation or orgasm (Specific questionnaires) | 90th postoperative day | 
| Quality-of-life evaluation (SF-36 questionnaire) | SF36 Domains: Role physical, Physical function, Role emotional, Energy, Emotional health, Social functioning, Bodily pain and General health. Scale ranging from 0 to 100, where zero is the worst state and 100 is the best. | 90th postoperative day | 
| Postoperative pain | Visual Analog Scale (VAS) score ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain | 90th postoperative day | 
| Follicle Stimulating Hormone (FSH) dosage | Serum FSH (IU/L) | 180th postoperative day | 
| Luteinizing Hormone (LH) dosage | Serum LH (IU/L) | 180th postoperative day | 
| Testosterone Hormone dosage | Serum Testosterone (ng/dl) | 180th postoperative day | 
| Sex hormone-binding globulin (SHGB) dosage | Serum SHGB (nmol/L) | 180th postoperative day | 
| Sexual activity | Satisfied or not with sexual performance, Changes in arousal, Changes in libido and Changes in ejaculation or orgasm (Specific questionnaires) | 180th postoperative day | 
| Quality-of-life evaluation (SF-36 questionnaire) | SF36 Domains: Role physical, Physical function, Role emotional, Energy, Emotional health, Social functioning, Bodily pain and General health. Scale ranging from 0 to 100, where zero is the worst state and 100 is the best. | 180th postoperative day | 
| Postoperative pain | Visual Analog Scale (VAS) score ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain | 180th postoperative day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inguinal hernia, Infertility, Laparoscopy