ASA Levels in TEP and Lichtenstein Repair Patients

Hernia, Inguinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03355950
• Other study ID #: E-16-1019
• Status: Recruiting
• Phase: N/A
• First received: January 30, 2017
• Last updated: November 22, 2017
• Start date: January 2017
• Est. completion date: August 2018

Study information

• Verified date: November 2017
• Source: Ankara Numune Training and Research Hospital
• Contact: Selami Ilgaz Kayilioglu, MD
• Phone: +90 533 203 6595
• Email: kayilioglu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Procedure:
• Lichtenstein Repair
Well defined Lichtenstein Repair for inguinal hernias
• TEP Repair
Laparoscopic totally extraperitoneal repair for inguianal hernias

Locations

Country	Name	City	State
Turkey	Ankara Numune Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Numune Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Anti-sperm antibody levels after inguinal hernia surgery	Samples will be collected before hernia surgery and three months after surgery	Three months for each patient
Secondary	Comparison of Anti-sperm antibody levels between inguinal hernia patients who have undergone laparoscopic totally extraperitoneal repair and Lichtenstein repair techniques		2 years anticipated