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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lichtenstein | Active Comparator | Conventional approach |
|
| Laparoscopy | Experimental | Experimental approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral hernioplasty | Procedure |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Follicle Stimulating Hormone (FSH) dosage | Serum FSH (IU/L) | Preoperative |
| Luteinizing Hormone (LH) dosage | Serum LH (IU/L) | Preoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClÃnicas da Faculdade de Medicina da Universidade de São Paulo | São Paulo | 05403-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37880447 | Derived | Damous SHB, Damous LL, Borges VA, Fontella AK, Miranda JDS, Koike MK, Saito OC, Birolini CAV, Utiyama EM. Bilateral inguinal hernia repair and male fertility: a randomized clinical trial comparing Lichtenstein versus laparoscopic transabdominal preperitoneal (TAPP) technique. Surg Endosc. 2023 Dec;37(12):9263-9274. doi: 10.1007/s00464-023-10499-8. Epub 2023 Oct 25. |
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All individual participant data that underlie individual participant data that underlie collected during the trial, after deidentification (text, tables, figures, and appendices) will be shared. Study Protocol also will be available. Data will be available immediately following publication, no end dates, to anyone who wishes to access the data, for any types of analyses. Proposals should be directed to sergio.damous@hc.fm.usp.br
Data will be available immediately following publication, no end dates.
Proposals should be directed to sergio.damous@hc.fm.usp.br
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized clinical trial with two groups, in according to hernioplasty correction approach
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Masking couldn't be possible because of the surgical technique
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 |
| 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 |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |