Long-term Follow-up After Laparoscopic Inguinal Hernia Repair Using Tisseel for Mesh Fixation

March 17, 2015 updated by: Andreas Qwist Fenger, Herlev Hospital

In hernia repair a mesh is used to close the defect in the abdominal wall. This mesh is either secured with tissue penetrating devices (ex. staples,tacks or sutures) or fibrin glue (Tisseel/Tissucol) or left unfixated.

The investigators believe, and previous studies indicate, that the use of fibrin glue greatly reduces the amount of postoperative complications (ex. chronic pain, impaired ejaculation in men or recurrence of the hernia)when compared with the use of tacks or staples.

The aim of this study is to compare the recurrence rates and amount of postoperative complications in patients who have had inguinal hernia repair with fibrin glue and in patients who have had inguinal hernia repair with tacks, staples or sutures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will use prospectively collected data from the Danish Hernia Database to find the patients. The patients will be contacted using a questionnaire.

Study Type

Observational

Enrollment (Actual)

2340

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

  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Hospital

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 will be enrolled based on their registration in the Danish Hernia Database. All patients in the database who have undergone laparoscopic inguinal hernia repair from January 2009 to September 2012 will be included.

Description

Inclusion Criteria:

inguinal hernia repair from January 2009-September 2012

Exclusion Criteria:

Patients lost to follow-up

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
Fibrin sealant group
Patients who have undergone laparoscopic inguinal hernia repair with fibrin sealant for mesh fixation
Procedure: Fibrin Sealant
Use of fibrin sealant for mesh fixation in laparoscopic inguinal hernia repair,
Other Names:
  • Tisseel
  • Fibrin glue
Tissue-penetrating fixation group
Patients who have undergone laparoscopic inguinal hernia repair with the use of tacks, staples or sutures for mesh fixation
Procedure: Tissue-penetrating mesh-fixation
Use of tacks, staples or sutures for mesh fixation in inguinal hernia repair
Other Names:
  • Protacks
  • Hernia stapler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic pain
Time Frame: within period from one year after procedure until follow-up
Reported pain (questionnaire) from one year after procedure
within period from one year after procedure until follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: within period from procedure to follow-up
Reherniation at repaired site. Defined as a clinically observable hernia or reoperation prior to follow-up
within period from procedure to follow-up
dysejaculation
Time Frame: Debut within period from procedure to follow-up
Reported ejaculatory dysfunction in male patients
Debut within period from procedure to follow-up

Collaborators and Investigators

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

Sponsor

Herlev Hospital

Investigators

  • Principal Investigator: Neel M Helvind, Researcher, Herlev Hospital
  • Study Chair: Jacob Rosenberg, professor, Herlev Hospital
  • Principal Investigator: Andreas Q Fenger, Researcher, Herlev Hospital

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

July 1, 2012

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

May 9, 2012

First Submitted That Met QC Criteria

May 10, 2012

First Posted (ESTIMATE)

May 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BS12-000733

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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