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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Herlev Hospital
Sponsor:
Information provided by (Responsible Party):
Andreas Qwist Fenger, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01597011
First received: May 9, 2012
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Hernia, Inguinal
Recurrence
Chronic Pain
Procedure: Tisseel
Procedure: Tissue-penetrating mesh-fixation

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Long-term Follow-up After Laparoscopic Inguinal Hernia Repair Using Tisseel for Mesh Fixation

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Chronic pain [ Time Frame: within period from one year after procedure until follow-up ] [ Designated as safety issue: No ]
    Reported pain (questionnaire) from one year after procedure


Secondary Outcome Measures:
  • Recurrence [ Time Frame: within period from procedure to follow-up ] [ Designated as safety issue: No ]
    Reherniation at repaired site. Defined as a clinically observable hernia or reoperation prior to follow-up

  • dysejaculation [ Time Frame: Debut within period from procedure to follow-up ] [ Designated as safety issue: No ]
    Reported ejaculatory dysfunction in male patients


Estimated Enrollment: 2340
Study Start Date: July 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tisseel group
Patients who have undergone inguinal hernia repair with fibrin sealant/fibrin glue/Tisseel for mesh fixation
Procedure: Tisseel
Use of Tisseel for mesh fixation in inguinal hernia repair,
Other Names:
  • Tisseel
  • Fibrin glue
  • Fibrin sealant
Tissue-penetrating fixation group
Patients who have undergone 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 inguinal hernia repair from June 1996 to June 2011 will be included

Criteria

Inclusion Criteria:

inguinal hernia repair from June 1996-June 2011

Exclusion Criteria:

Patients lost to follow-up

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597011

Contacts
Contact: Neel M Helvind, Researcher +45 27286810 neelhe@stud.ku.dk
Contact: Jacob Rosenberg, Professor +45 38683600 jacob.rosenberg@regionh.dk

Locations
Denmark
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Neel M Helvind, Researcher    +45 27286810    neelhe@stud.ku.dk   
Contact: Jacob Rosenberg, Professor    +45 38683600    jacob.rosenberg@regionh.dk   
Principal Investigator: Neel Helvind, Researcher         
Sub-Investigator: Jacob Rosenberg, Professor         
Sub-Investigator: Thue Bisgaard, Researcher         
Principal Investigator: Andreas Q Fenger, Researcher         
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Andreas Q Fenger, Researcher    +4522433593    andreas_fenger@hotmail.com   
Principal Investigator: Andreas Q Fenger, Researcher         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Andreas Qwist Fenger, BSc.Med., Herlev Hospital
ClinicalTrials.gov Identifier: NCT01597011     History of Changes
Other Study ID Numbers: BS12-000733
Study First Received: May 9, 2012
Last Updated: August 19, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Herlev Hospital:
Hernia, Inguinal
Hernia repair
Fibrin Tissue Adhesive
Tisseel
Tissucol
Recurrence
Chronic Pain
Dysejaculation

Additional relevant MeSH terms:
Hernia, Inguinal
Chronic Pain
Hernia
Recurrence
Disease Attributes
Hernia, Abdominal
Nervous System Diseases
Neurologic Manifestations
Pain
Pathologic Processes
Pathological Conditions, Anatomical
Signs and Symptoms
Fibrin Tissue Adhesive
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014