ASA Levels in TEP and Lichtenstein Repair Patients

Not Applicable

• Conditions: Hernia, Inguinal
• Interventions: Procedure: TEP Repair; Procedure: Lichtenstein Repair

• Registration Number: NCT03355950
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-30
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-22
• Last Update Submitted: 2017-11-22
• Study First Posted: 2017-11-29
• Last Update Posted: 2017-11-29
• Primary Completion: 2018-01
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 160

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEP group	TEP Repair	Patients who undergo totally extraperitoneal hernia repair, TEP Repair.
Lichtenstein group	Lichtenstein Repair	Patients who undergo Lichtenstein repair.

Primary Outcome Measures

Name	Time	Method
Change from baseline Anti-sperm antibody levels after inguinal hernia surgery	Three months for each patient	Samples will be collected before hernia surgery and three months after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ankara Numune Training and Research Hospital; 🇹🇷 Ankara, Turkey