An Efficiency/Safety Study of Surgical Tissue Glue to Treat Inguinal Hernias

NCT ID: NCT01669837

Last Updated: 2020-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2020-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Inguinal Hernia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient group

Administration of surgical tissue glue.

Mesh fixation with surgical tissue glue

Intervention Type DEVICE

Laparoscopic inguinal hernia repair using surgical tissue glue for mesh fixation

Interventions

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Mesh fixation with surgical tissue glue

Laparoscopic inguinal hernia repair using surgical tissue glue for mesh fixation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient is older than 18 years.
* Written informed consent is obtained from patient.
* Patient is able to complete the EQ-5D questionnaire.
* Patient has a primary unilateral or primary bilateral inguinal hernia- Mesh fixation is established with solely surgical tissue glue (Ifbond™).

Exclusion Criteria

* Patient has a recurrent inguinal hernia.
* Patient is treated using the Lichtenstein technique.
* Mesh fixation with sutures, tacks, absorbable tacks or clips.
* Patient is allergic to components of surgical tissue glue (Ifbond™).
* Patient has a life expectancy of less than 1 year.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duomed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kurt Van der Speeten, MD

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis Oost-Limburg

Locations

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Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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BM-IFA-06

Identifier Type: -

Identifier Source: org_study_id

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