CClinicalTrials.gg
Status unknownNCT03421925Updated Feb 5, 2018

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

An interventional study of Laparoscopic totally extraperitoneal procedure for inguinal hernia in Hernia, Inguinal, sponsored by Okan University. Status unknown at 1 site in Turkey. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-05.

Sponsored by Okan University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Male
01

Study 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

02

Conditions studied

  • Hernia, Inguinal
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

Patients with unilateral inguinal hernia Male patients

Exclusion criteria

-

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

-

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureLaparoscopic 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

05

What researchers measure

Primary outcomes

  1. Testicular volume

    Time frame: 6 months

Secondary outcomes

  1. Testicular artery blood flow

    Time frame: 6 months

06

Study locations

1 site
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03421925
Lead sponsor
Okan University
Responsible party
Murat Ferhat Ferhatoglu (Assistant Professor, M.D., Okan University) — Principal investigator
First posted
Feb 5, 2018
Start date
Feb 1, 2018 (estimated)
Primary completion
Feb 1, 2019 (estimated)
Completion
Feb 1, 2020 (estimated)
Last update
Feb 5, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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