Back to resultsASA Levels in TEP and Lichtenstein Repair Patients
Primary Purpose
Hernia, Inguinal
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lichtenstein Repair
TEP Repair
Sponsored by
About this trial
This is an interventional treatment trial for Hernia, Inguinal
Eligibility Criteria
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
Sites / Locations
- Ankara Numune Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
TEP group
Lichtenstein group
Arm Description
Patients who undergo totally extraperitoneal hernia repair, TEP Repair.
Patients who undergo Lichtenstein repair.
Outcomes
Primary Outcome Measures
Change from baseline Anti-sperm antibody levels after inguinal hernia surgery
Samples will be collected before hernia surgery and three months after surgery
Secondary Outcome Measures
Comparison of Anti-sperm antibody levels between inguinal hernia patients who have undergone laparoscopic totally extraperitoneal repair and Lichtenstein repair techniques
Full Information
NCT ID
NCT03355950
First Posted
January 30, 2017
Last Updated
November 22, 2017
Sponsor
Ankara City Hospital Bilkent
1. Study Identification
Unique Protocol Identification Number
NCT03355950
Brief Title
ASA Levels in TEP and Lichtenstein Repair Patients
Official Title
Comparison of Anti-sperm Antibody Levels in Inguinal Hernia Patients Who Undergo Totally Extra-peritoneal and Lichtenstein Repair
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ankara City Hospital Bilkent
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TEP group
Arm Type
Active Comparator
Arm Description
Patients who undergo totally extraperitoneal hernia repair, TEP Repair.
Arm Title
Lichtenstein group
Arm Type
Active Comparator
Arm Description
Patients who undergo Lichtenstein repair.
Intervention Type
Procedure
Intervention Name(s)
Lichtenstein Repair
Intervention Description
Well defined Lichtenstein Repair for inguinal hernias
Intervention Type
Procedure
Intervention Name(s)
TEP Repair
Intervention Description
Laparoscopic totally extraperitoneal repair for inguianal hernias
Primary Outcome Measure Information:
Title
Change from baseline Anti-sperm antibody levels after inguinal hernia surgery
Description
Samples will be collected before hernia surgery and three months after surgery
Time Frame
Three months for each patient
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Selami Ilgaz Kayılıoğlu, MD
Phone
+90 533 203 6595
Email
kayilioglu@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ömer Özduman, MD
Phone
+90 544 253 9683
Email
omer_ozduman@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faruk Coskun, MD, Prof
Organizational Affiliation
Ankara Numune Research and Training Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ankara Numune Training and Research Hospital
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selami Ilgaz Kayılıoğlu, MD
Phone
+905332036595
Email
kayilioglu@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ASA Levels in TEP and Lichtenstein Repair Patients
We'll reach out to this number within 24 hrs