Inguinal Hernia Bilateral
Conditions
Keywords
Inguinal hernia, Infertility, Laparoscopy
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).
Interventions
PROCEDUREBilateral hernioplasty
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Masking couldn't be possible because of the surgical technique
Intervention model description
Randomized clinical trial with two groups, in according to hernioplasty correction approach
Eligibility
Sex/Gender
MALE
Age
19 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sperm Volume | Preoperative | Sperm Volume (in ml) measured by Semen analysis |
| Sperm concentration | Preoperative | Sperm concentration (million sperm/ml) measured by Semen analysis |
| Sperm number | Preoperative | Sperm number in million measured by Semen analysis |
| Sperm motility | Preoperative | Sperm motility in % of progression measured by Semen analysis |
| Sperm morphology | Preoperative | Sperm morphology, according to the Kruger classification, evaluated by Semen analysis |
| Testicular volume | Preoperative | Testicular volume, in cm3, measured by testicular ultrasound |
| Testicular vascularization | Preoperative | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Follicle Stimulating Hormone (FSH) dosage | Preoperative | Serum FSH (IU/L) |
| Luteinizing Hormone (LH) dosage | Preoperative | Serum LH (IU/L) |
| Testosterone Hormone dosage | Preoperative | Serum Testosterone (ng/dl) |
| Sex hormone-binding globulin (SHGB) dosage | Preoperative | Serum SHGB (nmol/L) |
| Sexual activity | Preoperative | Satisfied or not with sexual performance, Changes in arousal, Changes in libido and Changes in ejaculation or orgasm (Specific questionnaires) |
| Quality-of-life evaluation (SF-36 questionnaire) | Preoperative | 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 | 7th postoperative day | Visual Analog Scale (VAS) score ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain |
Countries
Brazil
Outcome results
None listed