We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01597011
Recruitment Status : Completed
First Posted : May 11, 2012
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
Andreas Qwist Fenger, Herlev Hospital

Brief Summary:

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 or disease Intervention/treatment
Hernia, Inguinal Recurrence Chronic Pain Procedure: Fibrin Sealant Procedure: Tissue-penetrating mesh-fixation

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
Actual Enrollment : 2340 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Long-term Follow-up After Laparoscopic Inguinal Hernia Repair Using Tisseel for Mesh Fixation
Study Start Date : July 2012
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain Hernia
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Chronic pain [ Time Frame: within period from one year after procedure until follow-up ]
    Reported pain (questionnaire) from one year after procedure


Secondary Outcome Measures :
  1. 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

  2. dysejaculation [ Time Frame: Debut within period from procedure to follow-up ]
    Reported ejaculatory dysfunction in male patients



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 laparoscopic inguinal hernia repair from January 2009 to September 2012 will be included.
Criteria

Inclusion Criteria:

inguinal hernia repair from January 2009-September 2012

Exclusion Criteria:

Patients lost to follow-up


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597011


Locations
Denmark
Herlev Hospital
Herlev, Denmark, 2730
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

Responsible Party: Andreas Qwist Fenger, BSc.Med., Herlev Hospital
ClinicalTrials.gov Identifier: NCT01597011     History of Changes
Other Study ID Numbers: BS12-000733
First Posted: May 11, 2012    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015

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

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