Completed
Cyanoacrylate Fixation for Laparoscopic Repair of Inguinal Hernias: a Prospective, Multicenter Registry
What is being collected
Device Data
Collected from today forward - ProspectiveDevice
Who is being recruted
Hernia+2
+ Pathological Conditions, Signs and Symptoms
+ Pathological Conditions, Anatomical
Over 18 Years
+9 Eligibility Criteria
How is the trial designed
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Observational
Study Start: May 2012
Summary
Principal SponsorDuomed
Last updated: June 18, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2012
Actual date on which the first participant was enrolled.Prospective, multicenter, observational registry to collect data of laparoscopic inguinal hernia repair using surgical tissue glue fixation. The objective is to determine the prevalence of chronic pain at 1 year.
Principal SponsorDuomed
Last updated: June 18, 2020
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
1000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
HerniaPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalHernia, AbdominalHernia, Inguinal
Criteria
4 inclusion criteria required to participate
Patient has a primary unilateral or primary bilateral inguinal hernia- Mesh fixation is established with solely surgical tissue glue (IfbondTM)
Patient is able to complete the EQ-5D questionnaire
Patient is older than 18 years
Written informed consent is obtained from patient
5 exclusion criteria prevent from participating
Mesh fixation with sutures, tacks, absorbable tacks or clips
Patient has a life expectancy of less than 1 year
Patient has a recurrent inguinal hernia
Patient is allergic to components of surgical tissue glue (IfbondTM)
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center