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

June 18, 2020 updated by: Duomed

Cyanoacrylate Fixation for Laparoscopic Repair of Inguinal Hernias: a Prospective, Multicenter Registry

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Ziekenhuis Oost-Limburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a primary inguinal hernia

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient group
Administration of surgical tissue glue.
Device: Mesh fixation with surgical tissue glue
Laparoscopic inguinal hernia repair using surgical tissue glue for mesh fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: up to 1 year
Prevalence of postoperative pain evaluated by patient self-assessment using a visual analog scale.
up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative complications
Time Frame: 1 day
Complications such as bowel injury, major bleeding, complications due to anesthesia, nerve damage, lesion of vas deferens.
1 day
Postoperative complications
Time Frame: Up to 30 days after index-procedure
Local numbness, hematoma, seroma, wound infection, mesh infection, hernia recurrence.
Up to 30 days after index-procedure
Analgesic intake
Time Frame: Discharge, 5 weeks
Intake of analgesics.
Discharge, 5 weeks
Quality of life (QOL)
Time Frame: Preoperative, 5 weeks, 1 year
QOL assessed by EQ-5D questionnaire.
Preoperative, 5 weeks, 1 year
Freedom from hernia-related reinterventions
Time Frame: 1 year
Reinterventions at 1 year after index-procedure assessed by means of a questionnaire.
1 year
Late complications
Time Frame: 1 year
Local numbness, groin discomfort, hernia recurrence, sexual dysfunction
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duomed

Investigators

  • Principal Investigator: Kurt Van der Speeten, MD, Ziekenhuis Oost-Limburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2012

Primary Completion (ACTUAL)

March 1, 2020

Study Completion (ACTUAL)

March 1, 2020

Study Registration Dates

First Submitted

August 17, 2012

First Submitted That Met QC Criteria

August 20, 2012

First Posted (ESTIMATE)

August 21, 2012

Study Record Updates

Last Update Posted (ACTUAL)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 18, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BM-IFA-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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