Bilateral Inguinal Hernia Repair and Male Fertility: A Randomized Clinical Trial Comparing Lichtenstein Versus Laparoscopic Transabdominal Preperitoneal (TAPP) Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Sperm Volume
研究概览
简要总结
General objective: To evaluate the fertility of adult men submitted to bilateral herniorrhaphy with mesh placement by the Lichtenstein and laparoscopic approaches
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Masking couldn't be possible because of the surgical technique
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 19 and 60 years old
- •Bilateral inguinal hernia
- •Primary and reducible inguinal hernia
排除标准
- •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
结局指标
主要结局
Sperm Volume
时间窗: 180th postoperative day
Sperm Volume (in ml) measured by Semen analysis
Sperm number
时间窗: 180th postoperative day
Sperm number in million measured by Semen analysis
Sperm morphology
时间窗: 180th postoperative day
Sperm morphology, according to the Kruger classification, evaluated by Semen analysis
Sperm concentration
时间窗: 180th postoperative day
Sperm concentration (million sperm/ml) measured by Semen analysis
Testicular vascularization
时间窗: 180th postoperative day
Testicular vascularization, normal or not, measured by testicular Doppler ultrasound
Semen analysis
时间窗: 180th postoperative day
Volume (ml), Concentration (million/ml), Sperm number (million), Motility (% of progression), Morphology (Kruger classification)
Sperm motility
时间窗: 180th postoperative day
Sperm motility in % of progression measured by Semen analysis
Testicular volume
时间窗: 180th postoperative day
Testicular volume, in cm3, measured by testicular ultrasound
次要结局
- Luteinizing Hormone (LH) dosage(180th postoperative day)
- Quality-of-life evaluation (SF-36 questionnaire)(180th postoperative day)
- Postoperative pain(180th postoperative day)
- Follicle Stimulating Hormone (FSH) dosage(180th postoperative day)
- Testosterone Hormone dosage(180th postoperative day)
- Sex hormone-binding globulin (SHGB) dosage(180th postoperative day)
- Sexual activity(180th postoperative day)