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ASA Levels in TEP and Lichtenstein Repair Patients

NCT ID: NCT03355950

Last Updated: 2017-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Hernia, Inguinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TEP group

Patients who undergo totally extraperitoneal hernia repair, TEP Repair.

Group Type ACTIVE_COMPARATOR

TEP Repair

Intervention Type PROCEDURE

Laparoscopic totally extraperitoneal repair for inguianal hernias

Lichtenstein group

Patients who undergo Lichtenstein repair.

Group Type ACTIVE_COMPARATOR

Lichtenstein Repair

Intervention Type PROCEDURE

Well defined Lichtenstein Repair for inguinal hernias

Interventions

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Lichtenstein Repair

Well defined Lichtenstein Repair for inguinal hernias

Intervention Type PROCEDURE

TEP Repair

Laparoscopic totally extraperitoneal repair for inguianal hernias

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Faruk Coskun, MD, Prof

Role: STUDY_DIRECTOR

Ankara Numune Research and Training Hospital

Locations

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Ankara Numune Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Selami Ilgaz Kayılıoğlu, MD

Role: CONTACT

Phone: +90 533 203 6595

Email: [email protected]

Ömer Özduman, MD

Role: CONTACT

Phone: +90 544 253 9683

Email: [email protected]

Facility Contacts

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Selami Ilgaz Kayılıoğlu, MD

Role: primary

Other Identifiers

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E-16-1019

Identifier Type: -

Identifier Source: org_study_id