Back to resultsInguinal Hernia Repair and Male Fertility
Primary Purpose
Inguinal Hernia Bilateral
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Bilateral hernioplasty
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia Bilateral focused on measuring Inguinal hernia, Infertility, Laparoscopy
Eligibility Criteria
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
Sites / Locations
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Lichtenstein
Laparoscopy
Arm Description
Conventional approach
Experimental approach
Outcomes
Primary Outcome Measures
Sperm Volume
Sperm Volume (in ml) measured by Semen analysis
Sperm concentration
Sperm concentration (million sperm/ml) measured by Semen analysis
Sperm number
Sperm number in million measured by Semen analysis
Sperm motility
Sperm motility in % of progression measured by Semen analysis
Sperm morphology
Sperm morphology, according to the Kruger classification, evaluated by Semen analysis
Testicular volume
Testicular volume, in cm3, measured by testicular ultrasound
Testicular vascularization
Testicular vascularization, normal or not, measured by testicular Doppler ultrasound
Sperm Volume
Sperm Volume (in ml) measured by Semen analysis
Sperm concentration
Sperm concentration (million sperm/ml) measured by Semen analysis
Sperm number
Sperm number in million measured by Semen analysis
Sperm motility
Sperm motility in % of progression measured by Semen analysis
Sperm morphology
Sperm morphology, according to the Kruger classification, evaluated by Semen analysis
Testicular volume
Testicular volume, in cm3, measured by testicular ultrasound
Testicular vascularization
Testicular vascularization, normal or not, measured by testicular Doppler ultrasound
Sperm Volume
Sperm Volume (in ml) measured by Semen analysis
Sperm concentration
Sperm concentration (million sperm/ml) measured by Semen analysis
Sperm number
Sperm number in million measured by Semen analysis
Sperm motility
Sperm motility in % of progression measured by Semen analysis
Sperm morphology
Sperm morphology, according to the Kruger classification, evaluated by Semen analysis
Semen analysis
Volume (ml), Concentration (million/ml), Sperm number (million), Motility (% of progression), Morphology (Kruger classification)
Testicular volume
Testicular volume, in cm3, measured by testicular ultrasound
Testicular vascularization
Testicular vascularization, normal or not, measured by testicular Doppler ultrasound
Secondary Outcome Measures
Follicle Stimulating Hormone (FSH) dosage
Serum FSH (IU/L)
Luteinizing Hormone (LH) dosage
Serum LH (IU/L)
Testosterone Hormone dosage
Serum Testosterone (ng/dl)
Sex hormone-binding globulin (SHGB) dosage
Serum SHGB (nmol/L)
Sexual activity
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)
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
Visual Analog Scale (VAS) score ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain
Postoperative pain
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
Serum FSH (IU/L)
Luteinizing Hormone (LH) dosage
Serum LH (IU/L)
Testosterone Hormone dosage
Testosterone (ng/dl)
Sex hormone-binding globulin (SHGB) dosage
Serum SHGB (nmol/L)
Sexual activity
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)
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
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
Serum FSH (IU/L)
Luteinizing Hormone (LH) dosage
Serum LH (IU/L)
Testosterone Hormone dosage
Serum Testosterone (ng/dl)
Sex hormone-binding globulin (SHGB) dosage
Serum SHGB (nmol/L)
Sexual activity
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)
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
Visual Analog Scale (VAS) score ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain
Full Information
NCT ID
NCT05799742
First Posted
February 17, 2023
Last Updated
April 3, 2023
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT05799742
Brief Title
Inguinal Hernia Repair and Male Fertility
Official Title
Bilateral Inguinal Hernia Repair and Male Fertility: A Randomized Clinical Trial Comparing Lichtenstein Versus Laparoscopic Transabdominal Preperitoneal (TAPP) Technique
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia Bilateral
Keywords
Inguinal hernia, Infertility, Laparoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial with two groups, in according to hernioplasty correction approach
Masking
Outcomes Assessor
Masking Description
Masking couldn't be possible because of the surgical technique
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lichtenstein
Arm Type
Active Comparator
Arm Description
Conventional approach
Arm Title
Laparoscopy
Arm Type
Experimental
Arm Description
Experimental approach
Intervention Type
Procedure
Intervention Name(s)
Bilateral hernioplasty
Primary Outcome Measure Information:
Title
Sperm Volume
Description
Sperm Volume (in ml) measured by Semen analysis
Time Frame
Preoperative
Title
Sperm concentration
Description
Sperm concentration (million sperm/ml) measured by Semen analysis
Time Frame
Preoperative
Title
Sperm number
Description
Sperm number in million measured by Semen analysis
Time Frame
Preoperative
Title
Sperm motility
Description
Sperm motility in % of progression measured by Semen analysis
Time Frame
Preoperative
Title
Sperm morphology
Description
Sperm morphology, according to the Kruger classification, evaluated by Semen analysis
Time Frame
Preoperative
Title
Testicular volume
Description
Testicular volume, in cm3, measured by testicular ultrasound
Time Frame
Preoperative
Title
Testicular vascularization
Description
Testicular vascularization, normal or not, measured by testicular Doppler ultrasound
Time Frame
Preoperative
Title
Sperm Volume
Description
Sperm Volume (in ml) measured by Semen analysis
Time Frame
90th postoperative day
Title
Sperm concentration
Description
Sperm concentration (million sperm/ml) measured by Semen analysis
Time Frame
90th postoperative day
Title
Sperm number
Description
Sperm number in million measured by Semen analysis
Time Frame
90th postoperative day
Title
Sperm motility
Description
Sperm motility in % of progression measured by Semen analysis
Time Frame
90th postoperative day
Title
Sperm morphology
Description
Sperm morphology, according to the Kruger classification, evaluated by Semen analysis
Time Frame
90th postoperative day
Title
Testicular volume
Description
Testicular volume, in cm3, measured by testicular ultrasound
Time Frame
90th postoperative day
Title
Testicular vascularization
Description
Testicular vascularization, normal or not, measured by testicular Doppler ultrasound
Time Frame
90th postoperative day
Title
Sperm Volume
Description
Sperm Volume (in ml) measured by Semen analysis
Time Frame
180th postoperative day
Title
Sperm concentration
Description
Sperm concentration (million sperm/ml) measured by Semen analysis
Time Frame
180th postoperative day
Title
Sperm number
Description
Sperm number in million measured by Semen analysis
Time Frame
180th postoperative day
Title
Sperm motility
Description
Sperm motility in % of progression measured by Semen analysis
Time Frame
180th postoperative day
Title
Sperm morphology
Description
Sperm morphology, according to the Kruger classification, evaluated by Semen analysis
Time Frame
180th postoperative day
Title
Semen analysis
Description
Volume (ml), Concentration (million/ml), Sperm number (million), Motility (% of progression), Morphology (Kruger classification)
Time Frame
180th postoperative day
Title
Testicular volume
Description
Testicular volume, in cm3, measured by testicular ultrasound
Time Frame
180th postoperative day
Title
Testicular vascularization
Description
Testicular vascularization, normal or not, measured by testicular Doppler ultrasound
Time Frame
180th postoperative day
Secondary Outcome Measure Information:
Title
Follicle Stimulating Hormone (FSH) dosage
Description
Serum FSH (IU/L)
Time Frame
Preoperative
Title
Luteinizing Hormone (LH) dosage
Description
Serum LH (IU/L)
Time Frame
Preoperative
Title
Testosterone Hormone dosage
Description
Serum Testosterone (ng/dl)
Time Frame
Preoperative
Title
Sex hormone-binding globulin (SHGB) dosage
Description
Serum SHGB (nmol/L)
Time Frame
Preoperative
Title
Sexual activity
Description
Satisfied or not with sexual performance, Changes in arousal, Changes in libido and Changes in ejaculation or orgasm (Specific questionnaires)
Time Frame
Preoperative
Title
Quality-of-life evaluation (SF-36 questionnaire)
Description
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
Title
Postoperative pain
Description
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
Title
Postoperative pain
Description
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
Title
Follicle Stimulating Hormone (FSH) dosage
Description
Serum FSH (IU/L)
Time Frame
90th postoperative day
Title
Luteinizing Hormone (LH) dosage
Description
Serum LH (IU/L)
Time Frame
90th postoperative day
Title
Testosterone Hormone dosage
Description
Testosterone (ng/dl)
Time Frame
90th postoperative day
Title
Sex hormone-binding globulin (SHGB) dosage
Description
Serum SHGB (nmol/L)
Time Frame
90th postoperative day
Title
Sexual activity
Description
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
Title
Quality-of-life evaluation (SF-36 questionnaire)
Description
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
Title
Postoperative pain
Description
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
Title
Follicle Stimulating Hormone (FSH) dosage
Description
Serum FSH (IU/L)
Time Frame
180th postoperative day
Title
Luteinizing Hormone (LH) dosage
Description
Serum LH (IU/L)
Time Frame
180th postoperative day
Title
Testosterone Hormone dosage
Description
Serum Testosterone (ng/dl)
Time Frame
180th postoperative day
Title
Sex hormone-binding globulin (SHGB) dosage
Description
Serum SHGB (nmol/L)
Time Frame
180th postoperative day
Title
Sexual activity
Description
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
Title
Quality-of-life evaluation (SF-36 questionnaire)
Description
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
Title
Postoperative pain
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
Data will be available immediately following publication, no end dates.
IPD Sharing Access Criteria
Proposals should be directed to sergio.damous@hc.fm.usp.br
Learn more about this trial
Inguinal Hernia Repair and Male Fertility
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