ASA Levels in TEP and Lichtenstein Repair Patients

November 22, 2017 updated by: Ankara City Hospital Bilkent

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Recruiting
        • Ankara Numune Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TEP group
Patients who undergo totally extraperitoneal hernia repair, TEP Repair.
Procedure: TEP Repair
Laparoscopic totally extraperitoneal repair for inguianal hernias
Active Comparator: Lichtenstein group
Patients who undergo Lichtenstein repair.
Procedure: Lichtenstein Repair
Well defined Lichtenstein Repair for inguinal hernias

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Three months for each patient

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Study Director: Faruk Coskun, MD, Prof, Ankara Numune Research and Training Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

January 30, 2017

First Submitted That Met QC Criteria

November 22, 2017

First Posted (Actual)

November 29, 2017

Study Record Updates

Last Update Posted (Actual)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 22, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-16-1019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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