Clinical trial NCT05799742: 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
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia Bilateral
Keywords: Inguinal hernia
Infertility
Laparoscopy
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2023-04-05
Enrollment: 37
Sex: MALE
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial with two groups, in according to hernioplasty correction approach
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Sperm Volume
timeFrame: Preoperative
measure: Sperm concentration
timeFrame: Preoperative
measure: Sperm number
timeFrame: Preoperative
measure: Sperm motility
timeFrame: Preoperative
measure: Sperm morphology
timeFrame: Preoperative
measure: Testicular volume
timeFrame: Preoperative
measure: Testicular vascularization
timeFrame: Preoperative
measure: Sperm Volume
timeFrame: 90th postoperative day
measure: Sperm concentration
timeFrame: 90th postoperative day
measure: Sperm number
timeFrame: 90th postoperative day
measure: Sperm motility
timeFrame: 90th postoperative day
measure: Sperm morphology
timeFrame: 90th postoperative day
measure: Testicular volume
timeFrame: 90th postoperative day
measure: Testicular vascularization
timeFrame: 90th postoperative day
measure: Sperm Volume
timeFrame: 180th postoperative day
measure: Sperm concentration
timeFrame: 180th postoperative day
measure: Sperm number
timeFrame: 180th postoperative day
measure: Sperm motility
timeFrame: 180th postoperative day
measure: Sperm morphology
timeFrame: 180th postoperative day
measure: Semen analysis
timeFrame: 180th postoperative day
measure: Testicular volume
timeFrame: 180th postoperative day
measure: Testicular vascularization
timeFrame: 180th postoperative day
Secondary outcomes:
measure: Follicle Stimulating Hormone (FSH) dosage
timeFrame: Preoperative
measure: Luteinizing Hormone (LH) dosage
timeFrame: Preoperative
measure: Testosterone Hormone dosage
timeFrame: Preoperative
measure: Sex hormone-binding globulin (SHGB) dosage
timeFrame: Preoperative
measure: Sexual activity
timeFrame: Preoperative
measure: Quality-of-life evaluation (SF-36 questionnaire)
timeFrame: Preoperative
measure: Postoperative pain
timeFrame: 7th postoperative day
measure: Postoperative pain
timeFrame: 30th postoperative day
measure: Follicle Stimulating Hormone (FSH) dosage
timeFrame: 90th postoperative day
measure: Luteinizing Hormone (LH) dosage
timeFrame: 90th postoperative day
measure: Testosterone Hormone dosage
timeFrame: 90th postoperative day
measure: Sex hormone-binding globulin (SHGB) dosage
timeFrame: 90th postoperative day
measure: Sexual activity
timeFrame: 90th postoperative day
measure: Quality-of-life evaluation (SF-36 questionnaire)
timeFrame: 90th postoperative day
measure: Postoperative pain
timeFrame: 90th postoperative day
measure: Follicle Stimulating Hormone (FSH) dosage
timeFrame: 180th postoperative day
measure: Luteinizing Hormone (LH) dosage
timeFrame: 180th postoperative day
measure: Testosterone Hormone dosage
timeFrame: 180th postoperative day
measure: Sex hormone-binding globulin (SHGB) dosage
timeFrame: 180th postoperative day
measure: Sexual activity
timeFrame: 180th postoperative day
measure: Quality-of-life evaluation (SF-36 questionnaire)
timeFrame: 180th postoperative day
measure: Postoperative pain
timeFrame: 180th postoperative day
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
References: