Effects of Using Divided Mesh and Using a Non Divided Mesh on Testicular Blood Flow and Volume in Laparoscopic Hernia Repair
1 other identifier
interventional
150
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
January 26, 2018
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedFirst Posted
Study publicly available on registry
February 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedFebruary 5, 2018
February 1, 2018
1 year
January 26, 2018
February 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Testicular volume
6 months
Secondary Outcomes (1)
Testicular artery blood flow
6 months
Study Arms (2)
Divided mesh group
OTHERIn this group, surgeon will use a mesh divided in to two legs in laparoscopic totally extraperitoneal repair
Non divided mesh group
OTHERIn this group, surgeon will use a non divided mesh in laparoscopic totally extraperitoneal repair
Interventions
Laparoscopic totally extraperitoneal procedure for inguinal hernia is a technique that is done by not entering the peritoneal cavity
Eligibility Criteria
You may qualify if:
- Patients with unilateral inguinal hernia Male patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Okan Universitylead
Study Sites (1)
Okan University
Istanbul, 34734, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, M.D.
Study Record Dates
First Submitted
January 26, 2018
First Posted
February 5, 2018
Study Start
February 1, 2018
Primary Completion
February 1, 2019
Study Completion
February 1, 2020
Last Updated
February 5, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share