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Clinical Trials/NCT03355950
NCT03355950UnknownNot Applicable

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

Ankara City Hospital Bilkent1 site in 1 country160 target enrollmentStarted: January 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
160
Locations
1
Primary Endpoint
Change from baseline Anti-sperm antibody levels after inguinal hernia surgery

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
No

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

Arms & Interventions

TEP group

Active Comparator

Patients who undergo totally extraperitoneal hernia repair, TEP Repair.

Intervention: TEP Repair (Procedure)

Lichtenstein group

Active Comparator

Patients who undergo Lichtenstein repair.

Intervention: Lichtenstein Repair (Procedure)

Outcomes

Primary Outcomes

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

Time Frame: Three months for each patient

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

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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