跳至主要内容
临床试验/NCT03355950
NCT03355950Unknown不适用

Comparison of Anti-sperm Antibody Levels in Inguinal Hernia Patients Who Undergo Totally Extra-peritoneal and Lichtenstein Repair

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
160
试验地点
1
主要终点
Change from baseline Anti-sperm antibody levels after inguinal hernia surgery

研究概览

简要总结

The purpose of this study is to determine and compare the possible affects of two different inguinal hernia repair technique (TEP and Lichtenstein) on serum ASA levels.

详细描述

Antisperm antibody levels are thought to be indirect indicators of spermatic duct injuries. The investigators' ultimate goal is to draw a conclusion about the effect of the type of surgery on spermatic duct integrity. The investigators are going to collect serum samples from inguinal hernia patients before and after surgery. The investigators aim to assess the effect of surgery on antisperm antibody levels of patients who undergo Licthenstein and TEP repair. Preoperative antisperm antibody levels will serve as control levels for each patient group.

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
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •to accept the terms of the randomization and all study
  • •to have unilateral inguinal hernia and set for an inguinal hernia repair
  • •to be a father

排除标准

  • •to have any kind of autoimmune disorders
  • •any kind of infertility history
  • •to have a history of inguinal and/or genital surgery and/or trauma

研究组 & 干预措施

TEP group

Active Comparator

Patients who undergo totally extraperitoneal hernia repair, TEP Repair.

干预措施: TEP Repair (Procedure)

Lichtenstein group

Active Comparator

Patients who undergo Lichtenstein repair.

干预措施: Lichtenstein Repair (Procedure)

结局指标

主要结局

Change from baseline Anti-sperm antibody levels after inguinal hernia surgery

时间窗: Three months for each patient

Samples will be collected before hernia surgery and three months after surgery

次要结局

  • Comparison of Anti-sperm antibody levels between inguinal hernia patients who have undergone laparoscopic totally extraperitoneal repair and Lichtenstein repair techniques(2 years anticipated)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验