Inguinal Hernia Repair and Male Fertility

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

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia Bilateral
• Intervention / Treatment: Procedure: Bilateral hernioplasty

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-000
    • Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lichtenstein; Conventional approach	Procedure: Bilateral hernioplasty
Experimental: Laparoscopy; Experimental approach	Procedure: Bilateral hernioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follicle Stimulating Hormone (FSH) dosage	Serum FSH (IU/L)	Preoperative
Luteinizing Hormone (LH) dosage	Serum LH (IU/L)	Preoperative
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Infertility; Inguinal hernia; Laparoscopy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: 45535015.40000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No