Inguinal Hernia Repair and Male Fertility

Inguinal Hernia Bilateral Clinical Trial

Official title:

Bilateral Inguinal Hernia Repair and Male Fertility: A Randomized Clinical Trial Comparing Lichtenstein Versus Laparoscopic Transabdominal Preperitoneal (TAPP) Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05799742
• Other study ID #: 45535015.40000.0068
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: December 15, 2020

Study information

• Verified date: January 2019
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 15, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia Bilateral

Intervention

Procedure:
• Bilateral hernioplasty

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sperm Volume	Sperm Volume (in ml) measured by Semen analysis	Preoperative
Primary	Sperm concentration	Sperm concentration (million sperm/ml) measured by Semen analysis	Preoperative
Primary	Sperm number	Sperm number in million measured by Semen analysis	Preoperative
Primary	Sperm motility	Sperm motility in % of progression measured by Semen analysis	Preoperative
Primary	Sperm morphology	Sperm morphology, according to the Kruger classification, evaluated by Semen analysis	Preoperative
Primary	Testicular volume	Testicular volume, in cm3, measured by testicular ultrasound	Preoperative
Primary	Testicular vascularization	Testicular vascularization, normal or not, measured by testicular Doppler ultrasound	Preoperative
Primary	Sperm Volume	Sperm Volume (in ml) measured by Semen analysis	90th postoperative day
Primary	Sperm concentration	Sperm concentration (million sperm/ml) measured by Semen analysis	90th postoperative day
Primary	Sperm number	Sperm number in million measured by Semen analysis	90th postoperative day
Primary	Sperm motility	Sperm motility in % of progression measured by Semen analysis	90th postoperative day
Primary	Sperm morphology	Sperm morphology, according to the Kruger classification, evaluated by Semen analysis	90th postoperative day
Primary	Testicular volume	Testicular volume, in cm3, measured by testicular ultrasound	90th postoperative day
Primary	Testicular vascularization	Testicular vascularization, normal or not, measured by testicular Doppler ultrasound	90th postoperative day
Primary	Sperm Volume	Sperm Volume (in ml) measured by Semen analysis	180th postoperative day
Primary	Sperm concentration	Sperm concentration (million sperm/ml) measured by Semen analysis	180th postoperative day
Primary	Sperm number	Sperm number in million measured by Semen analysis	180th postoperative day
Primary	Sperm motility	Sperm motility in % of progression measured by Semen analysis	180th postoperative day
Primary	Sperm morphology	Sperm morphology, according to the Kruger classification, evaluated by Semen analysis	180th postoperative day
Primary	Semen analysis	Volume (ml), Concentration (million/ml), Sperm number (million), Motility (% of progression), Morphology (Kruger classification)	180th postoperative day
Primary	Testicular volume	Testicular volume, in cm3, measured by testicular ultrasound	180th postoperative day
Primary	Testicular vascularization	Testicular vascularization, normal or not, measured by testicular Doppler ultrasound	180th postoperative day
Secondary	Follicle Stimulating Hormone (FSH) dosage	Serum FSH (IU/L)	Preoperative
Secondary	Luteinizing Hormone (LH) dosage	Serum LH (IU/L)	Preoperative
Secondary	Testosterone Hormone dosage	Serum Testosterone (ng/dl)	Preoperative
Secondary	Sex hormone-binding globulin (SHGB) dosage	Serum SHGB (nmol/L)	Preoperative
Secondary	Sexual activity	Satisfied or not with sexual performance, Changes in arousal, Changes in libido and Changes in ejaculation or orgasm (Specific questionnaires)	Preoperative
Secondary	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
Secondary	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
Secondary	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
Secondary	Follicle Stimulating Hormone (FSH) dosage	Serum FSH (IU/L)	90th postoperative day
Secondary	Luteinizing Hormone (LH) dosage	Serum LH (IU/L)	90th postoperative day
Secondary	Testosterone Hormone dosage	Testosterone (ng/dl)	90th postoperative day
Secondary	Sex hormone-binding globulin (SHGB) dosage	Serum SHGB (nmol/L)	90th postoperative day
Secondary	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
Secondary	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
Secondary	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
Secondary	Follicle Stimulating Hormone (FSH) dosage	Serum FSH (IU/L)	180th postoperative day
Secondary	Luteinizing Hormone (LH) dosage	Serum LH (IU/L)	180th postoperative day
Secondary	Testosterone Hormone dosage	Serum Testosterone (ng/dl)	180th postoperative day
Secondary	Sex hormone-binding globulin (SHGB) dosage	Serum SHGB (nmol/L)	180th postoperative day
Secondary	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
Secondary	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
Secondary	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