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Inguinal Hernia Repair and Male Fertility

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05799742
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
37
Enrollment
1
Location
2
Arms
54.5
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bilateral hernioplasty
 N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized clinical trial with two groups, in according to hernioplasty correction approachRandomized clinical trial with two groups, in according to hernioplasty correction approach
Masking:
Single (Outcomes Assessor)
Masking Description:
Masking couldn't be possible because of the surgical technique
Primary Purpose:
Treatment
Official Title:
Bilateral Inguinal Hernia Repair and Male Fertility: A Randomized Clinical Trial Comparing Lichtenstein Versus Laparoscopic Transabdominal Preperitoneal (TAPP) Technique
Actual Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Jun 1, 2020
Actual Study Completion Date :
Dec 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Lichtenstein

Conventional approach

Procedure: Bilateral hernioplasty
Experimental: Laparoscopy

Experimental approach

Procedure: Bilateral hernioplasty

Outcome Measures

Primary Outcome Measures

  1. Sperm Volume [Preoperative]

    Sperm Volume (in ml) measured by Semen analysis

  2. Sperm concentration [Preoperative]

    Sperm concentration (million sperm/ml) measured by Semen analysis

  3. Sperm number [Preoperative]

    Sperm number in million measured by Semen analysis

  4. Sperm motility [Preoperative]

    Sperm motility in % of progression measured by Semen analysis

  5. Sperm morphology [Preoperative]

    Sperm morphology, according to the Kruger classification, evaluated by Semen analysis

  6. Testicular volume [Preoperative]

    Testicular volume, in cm3, measured by testicular ultrasound

  7. Testicular vascularization [Preoperative]

    Testicular vascularization, normal or not, measured by testicular Doppler ultrasound

  8. Sperm Volume [90th postoperative day]

    Sperm Volume (in ml) measured by Semen analysis

  9. Sperm concentration [90th postoperative day]

    Sperm concentration (million sperm/ml) measured by Semen analysis

  10. Sperm number [90th postoperative day]

    Sperm number in million measured by Semen analysis

  11. Sperm motility [90th postoperative day]

    Sperm motility in % of progression measured by Semen analysis

  12. Sperm morphology [90th postoperative day]

    Sperm morphology, according to the Kruger classification, evaluated by Semen analysis

  13. Testicular volume [90th postoperative day]

    Testicular volume, in cm3, measured by testicular ultrasound

  14. Testicular vascularization [90th postoperative day]

    Testicular vascularization, normal or not, measured by testicular Doppler ultrasound

  15. Sperm Volume [180th postoperative day]

    Sperm Volume (in ml) measured by Semen analysis

  16. Sperm concentration [180th postoperative day]

    Sperm concentration (million sperm/ml) measured by Semen analysis

  17. Sperm number [180th postoperative day]

    Sperm number in million measured by Semen analysis

  18. Sperm motility [180th postoperative day]

    Sperm motility in % of progression measured by Semen analysis

  19. Sperm morphology [180th postoperative day]

    Sperm morphology, according to the Kruger classification, evaluated by Semen analysis

  20. Semen analysis [180th postoperative day]

    Volume (ml), Concentration (million/ml), Sperm number (million), Motility (% of progression), Morphology (Kruger classification)

  21. Testicular volume [180th postoperative day]

    Testicular volume, in cm3, measured by testicular ultrasound

  22. Testicular vascularization [180th postoperative day]

    Testicular vascularization, normal or not, measured by testicular Doppler ultrasound

Secondary Outcome Measures

  1. Follicle Stimulating Hormone (FSH) dosage [Preoperative]

    Serum FSH (IU/L)

  2. Luteinizing Hormone (LH) dosage [Preoperative]

    Serum LH (IU/L)

  3. Testosterone Hormone dosage [Preoperative]

    Serum Testosterone (ng/dl)

  4. Sex hormone-binding globulin (SHGB) dosage [Preoperative]

    Serum SHGB (nmol/L)

  5. Sexual activity [Preoperative]

    Satisfied or not with sexual performance, Changes in arousal, Changes in libido and Changes in ejaculation or orgasm (Specific questionnaires)

  6. 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.

  7. 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

  8. Postoperative pain [30th postoperative day]

    Visual Analog Scale (VAS) score ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain

  9. Follicle Stimulating Hormone (FSH) dosage [90th postoperative day]

    Serum FSH (IU/L)

  10. Luteinizing Hormone (LH) dosage [90th postoperative day]

    Serum LH (IU/L)

  11. Testosterone Hormone dosage [90th postoperative day]

    Testosterone (ng/dl)

  12. Sex hormone-binding globulin (SHGB) dosage [90th postoperative day]

    Serum SHGB (nmol/L)

  13. Sexual activity [90th postoperative day]

    Satisfied or not with sexual performance, Changes in arousal, Changes in libido and Changes in ejaculation or orgasm (Specific questionnaires)

  14. Quality-of-life evaluation (SF-36 questionnaire) [90th 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.

  15. Postoperative pain [90th postoperative day]

    Visual Analog Scale (VAS) score ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain

  16. Follicle Stimulating Hormone (FSH) dosage [180th postoperative day]

    Serum FSH (IU/L)

  17. Luteinizing Hormone (LH) dosage [180th postoperative day]

    Serum LH (IU/L)

  18. Testosterone Hormone dosage [180th postoperative day]

    Serum Testosterone (ng/dl)

  19. Sex hormone-binding globulin (SHGB) dosage [180th postoperative day]

    Serum SHGB (nmol/L)

  20. 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)

  21. 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.

  22. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 60 Years
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo São Paulo Brazil 05403-000

Sponsors and Collaborators

  • University of Sao Paulo General Hospital
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT05799742
Other Study ID Numbers:
  • 45535015.40000.0068
First Posted:
Apr 5, 2023
Last Update Posted:
Apr 5, 2023
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Sao Paulo General Hospital
Inguinal hernia
Infertility
Laparoscopy
Additional relevant MeSH terms:
Hernia
Hernia, Inguinal

Study Results

No Results Posted as of Apr 5, 2023