Inguinal Hernia Repair and Male Fertility
- Conditions
- Inguinal Hernia Bilateral
- Interventions
- Procedure: Bilateral hernioplasty
- Registration Number
- NCT05799742
- Lead Sponsor
- University of Sao Paulo General Hospital
- Brief Summary
General objective: To evaluate the fertility of adult men submitted to bilateral herniorrhaphy with mesh placement by the Lichtenstein and laparoscopic approaches
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 37
- Male
- Age between 19 and 60 years old
- Bilateral inguinal hernia
- Primary and reducible inguinal hernia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lichtenstein Bilateral hernioplasty Conventional approach Laparoscopy Bilateral hernioplasty Experimental approach
- Primary Outcome Measures
Name Time Method Sperm Volume 180th postoperative day Sperm Volume (in ml) measured by Semen analysis
Sperm number 180th postoperative day Sperm number in million measured by Semen analysis
Sperm morphology 180th postoperative day Sperm morphology, according to the Kruger classification, evaluated by Semen analysis
Sperm concentration 180th postoperative day Sperm concentration (million sperm/ml) measured by Semen analysis
Testicular vascularization 180th postoperative day Testicular vascularization, normal or not, measured by testicular Doppler ultrasound
Semen analysis 180th postoperative day Volume (ml), Concentration (million/ml), Sperm number (million), Motility (% of progression), Morphology (Kruger classification)
Sperm motility 180th postoperative day Sperm motility in % of progression measured by Semen analysis
Testicular volume 180th postoperative day Testicular volume, in cm3, measured by testicular ultrasound
- Secondary Outcome Measures
Name Time Method Luteinizing Hormone (LH) dosage 180th postoperative day Serum LH (IU/L)
Quality-of-life evaluation (SF-36 questionnaire) 180th postoperative day 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.
Postoperative pain 180th postoperative day Visual Analog Scale (VAS) score ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain
Follicle Stimulating Hormone (FSH) dosage 180th postoperative day Serum FSH (IU/L)
Testosterone Hormone dosage 180th postoperative day Serum Testosterone (ng/dl)
Sex hormone-binding globulin (SHGB) dosage 180th postoperative day Serum SHGB (nmol/L)
Sexual activity 180th postoperative day Satisfied or not with sexual performance, Changes in arousal, Changes in libido and Changes in ejaculation or orgasm (Specific questionnaires)
Trial Locations
- Locations (1)
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
🇧🇷São Paulo, Brazil