NCT01597011

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,340 (actual)
• Sponsor: Herlev Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hernia, Inguinal
• Recurrence
• Chronic Pain

Interventions

Type	Name	Description
PROCEDURE	Fibrin Sealant	Use of fibrin sealant for mesh fixation in laparoscopic inguinal hernia repair,
PROCEDURE	Tissue-penetrating mesh-fixation	Use of tacks, staples or sutures for mesh fixation in inguinal hernia repair

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-05-11
• Last updated: 2015-03-18

Locations

1 site across 1 country: Denmark