NCT03355950

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
10 months until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

January 30, 2017

Last Update Submit

November 22, 2017

Conditions

Hernia, Inguinal

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    2 years anticipated

Study Arms (2)

TEP group

ACTIVE COMPARATOR

Patients who undergo totally extraperitoneal hernia repair, TEP Repair.

Procedure: TEP Repair

Lichtenstein group

ACTIVE COMPARATOR

Patients who undergo Lichtenstein repair.

Procedure: Lichtenstein Repair

Interventions

Lichtenstein RepairPROCEDURE

Well defined Lichtenstein Repair for inguinal hernias

Lichtenstein group
TEP RepairPROCEDURE

Laparoscopic totally extraperitoneal repair for inguianal hernias

TEP group

Eligibility Criteria

Age20 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Numune Training and Research Hospital

Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Faruk Coskun, MD, Prof

    Ankara Numune Research and Training Hospital

    STUDY DIRECTOR

Central Study Contacts

Selami Ilgaz Kayılıoğlu, MD

CONTACT

+90 533 203 6595kayilioglu@yahoo.com

Ömer Özduman, MD

CONTACT

+90 544 253 9683omer_ozduman@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2017

First Posted

November 29, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

August 1, 2018

Last Updated

November 29, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)