General objective: To evaluate the fertility of adult men submitted to bilateral herniorrhaphy with mesh placement by the Lichtenstein and laparoscopic approaches
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
37
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil
Sperm Volume
Sperm Volume (in ml) measured by Semen analysis
Time frame: Preoperative
Sperm concentration
Sperm concentration (million sperm/ml) measured by Semen analysis
Time frame: Preoperative
Sperm number
Sperm number in million measured by Semen analysis
Time frame: Preoperative
Sperm motility
Sperm motility in % of progression measured by Semen analysis
Time frame: Preoperative
Sperm morphology
Sperm morphology, according to the Kruger classification, evaluated by Semen analysis
Time frame: Preoperative
Testicular volume
Testicular volume, in cm3, measured by testicular ultrasound
Time frame: Preoperative
Testicular vascularization
Testicular vascularization, normal or not, measured by testicular Doppler ultrasound
Time frame: Preoperative
Sperm Volume
Sperm Volume (in ml) measured by Semen analysis
Time frame: 90th postoperative day
Sperm concentration
Sperm concentration (million sperm/ml) measured by Semen analysis
Time frame: 90th postoperative day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sperm number
Sperm number in million measured by Semen analysis
Time frame: 90th postoperative day
Sperm motility
Sperm motility in % of progression measured by Semen analysis
Time frame: 90th postoperative day
Sperm morphology
Sperm morphology, according to the Kruger classification, evaluated by Semen analysis
Time frame: 90th postoperative day
Testicular volume
Testicular volume, in cm3, measured by testicular ultrasound
Time frame: 90th postoperative day
Testicular vascularization
Testicular vascularization, normal or not, measured by testicular Doppler ultrasound
Time frame: 90th postoperative day
Sperm Volume
Sperm Volume (in ml) measured by Semen analysis
Time frame: 180th postoperative day
Sperm concentration
Sperm concentration (million sperm/ml) measured by Semen analysis
Time frame: 180th postoperative day
Sperm number
Sperm number in million measured by Semen analysis
Time frame: 180th postoperative day
Sperm motility
Sperm motility in % of progression measured by Semen analysis
Time frame: 180th postoperative day
Sperm morphology
Sperm morphology, according to the Kruger classification, evaluated by Semen analysis
Time frame: 180th postoperative day
Semen analysis
Volume (ml), Concentration (million/ml), Sperm number (million), Motility (% of progression), Morphology (Kruger classification)
Time frame: 180th postoperative day
Testicular volume
Testicular volume, in cm3, measured by testicular ultrasound
Time frame: 180th postoperative day
Testicular vascularization
Testicular vascularization, normal or not, measured by testicular Doppler ultrasound
Time frame: 180th postoperative day
Follicle Stimulating Hormone (FSH) dosage
Serum FSH (IU/L)
Time frame: Preoperative
Luteinizing Hormone (LH) dosage
Serum LH (IU/L)
Time frame: Preoperative
Testosterone Hormone dosage
Serum Testosterone (ng/dl)
Time frame: Preoperative
Sex hormone-binding globulin (SHGB) dosage
Serum SHGB (nmol/L)
Time frame: Preoperative
Sexual activity
Satisfied or not with sexual performance, Changes in arousal, Changes in libido and Changes in ejaculation or orgasm (Specific questionnaires)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 30th postoperative day
Follicle Stimulating Hormone (FSH) dosage
Serum FSH (IU/L)
Time frame: 90th postoperative day
Luteinizing Hormone (LH) dosage
Serum LH (IU/L)
Time frame: 90th postoperative day
Testosterone Hormone dosage
Testosterone (ng/dl)
Time frame: 90th postoperative day
Sex hormone-binding globulin (SHGB) dosage
Serum SHGB (nmol/L)
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 90th postoperative day
Follicle Stimulating Hormone (FSH) dosage
Serum FSH (IU/L)
Time frame: 180th postoperative day
Luteinizing Hormone (LH) dosage
Serum LH (IU/L)
Time frame: 180th postoperative day
Testosterone Hormone dosage
Serum Testosterone (ng/dl)
Time frame: 180th postoperative day
Sex hormone-binding globulin (SHGB) dosage
Serum SHGB (nmol/L)
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 180th postoperative day