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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597011
• Other study ID #: BS12-000733
• Status: Completed
• Phase: N/A
• First received: May 9, 2012
• Last updated: March 17, 2015
• Start date: July 2012
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2340
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

inguinal hernia repair from January 2009-September 2012

Exclusion Criteria:

Patients lost to follow-up

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain
• Hernia
• Hernia, Inguinal
• Recurrence

Intervention

Procedure:
• Fibrin Sealant
Use of fibrin sealant for mesh fixation in laparoscopic inguinal hernia repair,
• Tissue-penetrating mesh-fixation
Use of tacks, staples or sutures for mesh fixation in inguinal hernia repair

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic pain	Reported pain (questionnaire) from one year after procedure	within period from one year after procedure until follow-up	No
Secondary	Recurrence	Reherniation at repaired site. Defined as a clinically observable hernia or reoperation prior to follow-up	within period from procedure to follow-up	No
Secondary	dysejaculation	Reported ejaculatory dysfunction in male patients	Debut within period from procedure to follow-up	No