Inguinal Hernia BilateralNCT05799742
Inguinal Hernia Repair and Male Fertility
A study testing Bilateral hernioplasty in people with Inguinal Hernia Bilateral, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
General objective: To evaluate the fertility of adult men submitted to bilateral herniorrhaphy with mesh placement by the Lichtenstein and laparoscopic approaches Read more about this study
- Who is it for?
- Ages 19 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia Bilateral
- What is being tested?
- Bilateral hernioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2016to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Age between 19 and 60 years old
- Bilateral inguinal hernia
- Primary and reducible inguinal hernia
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403-000
About this study
Official title: Bilateral Inguinal Hernia Repair and Male Fertility: A Randomized Clinical Trial Comparing Lichtenstein Versus Laparoscopic Transabdominal Preperitoneal (TAPP) Technique
General objective: To evaluate the fertility of adult men submitted to bilateral herniorrhaphy with mesh placement by the Lichtenstein and laparoscopic approaches
Read the 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).
- Conditions
- Inguinal Hernia Bilateral
- Being tested
- Bilateral hernioplasty
- Keywords
- Inguinal hernia, Infertility, Laparoscopy
- Medical subject headings
- Hernia, Inguinal, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral hernioplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Lichtenstein | Active comparator | Conventional approach Receives: Procedure: Bilateral hernioplasty |
| Laparoscopy | Experimental | Experimental approach Receives: Procedure: Bilateral hernioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm Volume
Sperm Volume (in ml) measured by Semen analysis
Measured: Preoperative
Sperm concentration
Sperm concentration (million sperm/ml) measured by Semen analysis
Measured: Preoperative
Sperm number
Sperm number in million measured by Semen analysis
Measured: Preoperative
Sperm motility
Sperm motility in % of progression measured by Semen analysis
Measured: Preoperative
Sperm morphology
Sperm morphology, according to the Kruger classification, evaluated by Semen analysis
Measured: Preoperative
Testicular volume
Testicular volume, in cm3, measured by testicular ultrasound
Measured: Preoperative
Testicular vascularization
Testicular vascularization, normal or not, measured by testicular Doppler ultrasound
Measured: Preoperative
Sperm Volume
Sperm Volume (in ml) measured by Semen analysis
Measured: 90th postoperative day
Sperm concentration
Sperm concentration (million sperm/ml) measured by Semen analysis
Measured: 90th postoperative day
Sperm number
Sperm number in million measured by Semen analysis
Measured: 90th postoperative day
Sperm motility
Sperm motility in % of progression measured by Semen analysis
Measured: 90th postoperative day
Sperm morphology
Sperm morphology, according to the Kruger classification, evaluated by Semen analysis
Measured: 90th postoperative day
Testicular volume
Testicular volume, in cm3, measured by testicular ultrasound
Measured: 90th postoperative day
Testicular vascularization
Testicular vascularization, normal or not, measured by testicular Doppler ultrasound
Measured: 90th postoperative day
Sperm Volume
Sperm Volume (in ml) measured by Semen analysis
Measured: 180th postoperative day
Sperm concentration
Sperm concentration (million sperm/ml) measured by Semen analysis
Measured: 180th postoperative day
Sperm number
Sperm number in million measured by Semen analysis
Measured: 180th postoperative day
Sperm motility
Sperm motility in % of progression measured by Semen analysis
Measured: 180th postoperative day
Sperm morphology
Sperm morphology, according to the Kruger classification, evaluated by Semen analysis
Measured: 180th postoperative day
Semen analysis
Volume (ml), Concentration (million/ml), Sperm number (million), Motility (% of progression), Morphology (Kruger classification)
Measured: 180th postoperative day
Testicular volume
Testicular volume, in cm3, measured by testicular ultrasound
Measured: 180th postoperative day
Testicular vascularization
Testicular vascularization, normal or not, measured by testicular Doppler ultrasound
Measured: 180th postoperative day
Secondary outcomes (22)
Follicle Stimulating Hormone (FSH) dosage
Serum FSH (IU/L)
Measured: Preoperative
Luteinizing Hormone (LH) dosage
Serum LH (IU/L)
Measured: Preoperative
Testosterone Hormone dosage
Serum Testosterone (ng/dl)
Measured: Preoperative
Sex hormone-binding globulin (SHGB) dosage
Serum SHGB (nmol/L)
Measured: Preoperative
Sexual activity
Satisfied or not with sexual performance, Changes in arousal, Changes in libido and Changes in ejaculation or orgasm (Specific questionnaires)
Measured: 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.
Measured: 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
Measured: 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
Measured: 30th postoperative day
Follicle Stimulating Hormone (FSH) dosage
Serum FSH (IU/L)
Measured: 90th postoperative day
Luteinizing Hormone (LH) dosage
Serum LH (IU/L)
Measured: 90th postoperative day
Testosterone Hormone dosage
Testosterone (ng/dl)
Measured: 90th postoperative day
Sex hormone-binding globulin (SHGB) dosage
Serum SHGB (nmol/L)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 90th postoperative day
Follicle Stimulating Hormone (FSH) dosage
Serum FSH (IU/L)
Measured: 180th postoperative day
Luteinizing Hormone (LH) dosage
Serum LH (IU/L)
Measured: 180th postoperative day
Testosterone Hormone dosage
Serum Testosterone (ng/dl)
Measured: 180th postoperative day
Sex hormone-binding globulin (SHGB) dosage
Serum SHGB (nmol/L)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 180th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Jun 2016
- Primary completion1 Jun 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal Hernia BilateralStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial with two groups, in according to hernioplasty correction approach
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799742
- Sponsor's protocol ID
- 45535015.40000.0068
- Status last verified
- Jan 2019
- First submitted
- 17 Feb 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 37880447
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Inguinal Hernia Repair and Male Fertility: A Randomized Clinical Trial Comparing Lichtenstein Versus Laparoscopic Transabdominal Preperitoneal (TAPP) Technique
- ClinicalTrials.gov ID
- NCT05799742
- Acronym / sponsor ID
- 45535015.40000.0068
- Conditions
- Inguinal Hernia Bilateral
- Keywords
- Inguinal hernia, Infertility, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial with two groups, in according to hernioplasty correction approach
| Arm | Type | Receives |
|---|---|---|
| Lichtenstein | Active comparator | Procedure: Bilateral hernioplastyConventional approach |
| Laparoscopy | Experimental | Procedure: Bilateral hernioplastyExperimental approach |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- Age between 19 and 60 years old
- Bilateral inguinal hernia
- Primary and reducible inguinal hernia
Key exclusion criteria (15 listed)
- Age less than 19 or more than 60 years old
- ASA >III
- Genito-urinary infection
- Immunodeficiency
- History of testicular trauma2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral hernioplasty | Procedure or surgery | Laparoscopy, Lichtenstein |
Primary outcome
Sperm Volume
Time frame: Preoperative
Sperm Volume (in ml) measured by Semen analysis
Sperm concentration
Time frame: Preoperative
Sperm concentration (million sperm/ml) measured by Semen analysis
Sperm number
Time frame: Preoperative
Sperm number in million measured by Semen analysis
Sperm motility
Time frame: Preoperative
Sperm motility in % of progression measured by Semen analysis
Sperm morphology
Time frame: Preoperative
Sperm morphology, according to the Kruger classification, evaluated by Semen analysis
Testicular volume
Time frame: Preoperative
Testicular volume, in cm3, measured by testicular ultrasound
Testicular vascularization
Time frame: Preoperative
Testicular vascularization, normal or not, measured by testicular Doppler ultrasound
Sperm Volume
Time frame: 90th postoperative day
Sperm Volume (in ml) measured by Semen analysis
Sperm concentration
Time frame: 90th postoperative day
Sperm concentration (million sperm/ml) measured by Semen analysis
Sperm number
Time frame: 90th postoperative day
Sperm number in million measured by Semen analysis
Sperm motility
Time frame: 90th postoperative day
Sperm motility in % of progression measured by Semen analysis
Sperm morphology
Time frame: 90th postoperative day
Sperm morphology, according to the Kruger classification, evaluated by Semen analysis
Testicular volume
Time frame: 90th postoperative day
Testicular volume, in cm3, measured by testicular ultrasound
Testicular vascularization
Time frame: 90th postoperative day
Testicular vascularization, normal or not, measured by testicular Doppler ultrasound
Sperm Volume
Time frame: 180th postoperative day
Sperm Volume (in ml) measured by Semen analysis
Sperm concentration
Time frame: 180th postoperative day
Sperm concentration (million sperm/ml) measured by Semen analysis
Sperm number
Time frame: 180th postoperative day
Sperm number in million measured by Semen analysis
Sperm motility
Time frame: 180th postoperative day
Sperm motility in % of progression measured by Semen analysis
Sperm morphology
Time frame: 180th postoperative day
Sperm morphology, according to the Kruger classification, evaluated by Semen analysis
Semen analysis
Time frame: 180th postoperative day
Volume (ml), Concentration (million/ml), Sperm number (million), Motility (% of progression), Morphology (Kruger classification)
Testicular volume
Time frame: 180th postoperative day
Testicular volume, in cm3, measured by testicular ultrasound
Testicular vascularization
Time frame: 180th postoperative day
Testicular vascularization, normal or not, measured by testicular Doppler ultrasound
22 secondary outcomes
Follicle Stimulating Hormone (FSH) dosage
Time frame: Preoperative
Luteinizing Hormone (LH) dosage
Time frame: Preoperative
Testosterone Hormone dosage
Time frame: Preoperative
Sex hormone-binding globulin (SHGB) dosage
Time frame: Preoperative
Sexual activity
Time frame: Preoperative
Quality-of-life evaluation (SF-36 questionnaire)
Time frame: Preoperative
Postoperative pain
Time frame: 7th postoperative day
Postoperative pain
Time frame: 30th postoperative day
Follicle Stimulating Hormone (FSH) dosage
Time frame: 90th postoperative day
Luteinizing Hormone (LH) dosage
Time frame: 90th postoperative day
Testosterone Hormone dosage
Time frame: 90th postoperative day
Sex hormone-binding globulin (SHGB) dosage
Time frame: 90th postoperative day
Sexual activity
Time frame: 90th postoperative day
Quality-of-life evaluation (SF-36 questionnaire)
Time frame: 90th postoperative day
Postoperative pain
Time frame: 90th postoperative day
Follicle Stimulating Hormone (FSH) dosage
Time frame: 180th postoperative day
Luteinizing Hormone (LH) dosage
Time frame: 180th postoperative day
Testosterone Hormone dosage
Time frame: 180th postoperative day
Sex hormone-binding globulin (SHGB) dosage
Time frame: 180th postoperative day
Sexual activity
Time frame: 180th postoperative day
Quality-of-life evaluation (SF-36 questionnaire)
Time frame: 180th postoperative day
Postoperative pain
Time frame: 180th postoperative day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Derived from this study: PubMed 37880447Damous 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral hernioplasty in people with Inguinal Hernia Bilateral, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm Volume (time frame: Preoperative). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05799742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.