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

Primary Purpose

Hernia, Inguinal

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Laparoscopic totally extraperitoneal procedure for inguinal hernia

About this trial

This is an interventional treatment trial for Hernia, Inguinal

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Okan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Divided mesh group

Non divided mesh group

Arm Description

In this group, surgeon will use a mesh divided in to two legs in laparoscopic totally extraperitoneal repair

In this group, surgeon will use a non divided mesh in laparoscopic totally extraperitoneal repair

Outcomes

Primary Outcome Measures

Testicular volume

Secondary Outcome Measures

Testicular artery blood flow

Full Information

NCT ID

NCT03421925

First Posted

January 26, 2018

Last Updated

February 2, 2018

Sponsor

Okan University

1. Study Identification

Unique Protocol Identification Number

NCT03421925

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2018 (Anticipated)

Primary Completion Date

February 1, 2019 (Anticipated)

Study Completion Date

February 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Okan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

Outcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Divided mesh group

Arm Type

Other

Arm Description

In this group, surgeon will use a mesh divided in to two legs in laparoscopic totally extraperitoneal repair

Arm Title

Non divided mesh group

Arm Type

Other

Arm Description

In this group, surgeon will use a non divided mesh in laparoscopic totally extraperitoneal repair

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic totally extraperitoneal procedure for inguinal hernia

Intervention Description

Laparoscopic totally extraperitoneal procedure for inguinal hernia is a technique that is done by not entering the peritoneal cavity

Primary Outcome Measure Information:

Title

Testicular volume

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Testicular artery blood flow

Time Frame

6 months

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

In this study, we are going to measure parameters about testicles.

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Facility Information:

Facility Name

Okan University

City

Istanbul

ZIP/Postal Code

34734

Country

Turkey

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Murat Ferhat Ferhatoglu, M.D.

Phone

+905553214793

ferhatferhatoglu@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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