Effects of Using Divided Mesh and Using a Non Divided Mesh on Testicular Blood Flow and Volume in Laparoscopic Hernia Repair

February 2, 2018 updated by: Murat Ferhat Ferhatoglu, Okan University
Laparoscopic inguinal hernia repair techniques has been compared with the open techniques in several studies. However, no one studied about the different uses of the same type of mesh on the same surgical technique, and effects of this different use on testicular volume and blood flow. The objective of this study is to investigate the effects at 6 months of the divided and non divided mesh in laparoscopic totally extraperitoneal hernia repair technique on testicular volume and blood flow by use of Doppler Ultrasonography

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

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
      • Istanbul, Turkey, 34734
        • Okan University

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Patients with unilateral inguinal hernia Male patients

-

Exclusion Criteria:

Patients have femoral hernia Patients have bilateral inguinal hernia Patients have recurrent inguinal hernia Female patients Patients with history of pelvic surgery Patients with history of pelvic major trauma Patients with history of pelvic radiotherapy Patients have previous scrotal trauma or surgery history Patients have heavy cardiac diseases, pulmonary diseases Patients have benign prostate hyperplasia Patients have history of incarceration of inguinal hernia

-

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Divided mesh group
In this group, surgeon will use a mesh divided in to two legs in laparoscopic totally extraperitoneal repair
Procedure: Laparoscopic totally extraperitoneal procedure for inguinal hernia
Laparoscopic totally extraperitoneal procedure for inguinal hernia is a technique that is done by not entering the peritoneal cavity
Other: Non divided mesh group
In this group, surgeon will use a non divided mesh in laparoscopic totally extraperitoneal repair
Procedure: Laparoscopic totally extraperitoneal procedure for inguinal hernia
Laparoscopic totally extraperitoneal procedure for inguinal hernia is a technique that is done by not entering the peritoneal cavity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Testicular volume
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Testicular artery blood flow
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Okan University

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 (Anticipated)

February 1, 2018

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

January 26, 2018

First Submitted That Met QC Criteria

February 2, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 2, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OkanU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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