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

Completed

• Conditions: Chronic Pain; Hernia, Inguinal; Recurrence
• Interventions: Procedure: Fibrin Sealant; Procedure: Tissue-penetrating mesh-fixation

• Registration Number: NCT01597011
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-10
• Study First Posted: 2012-05-11
• Study Start: 2012-07
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2340

Inclusion Criteria

inguinal hernia repair from January 2009-September 2012

Exclusion Criteria

Patients lost to follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fibrin sealant group	Fibrin Sealant	Patients who have undergone laparoscopic inguinal hernia repair with fibrin sealant for mesh fixation
Tissue-penetrating fixation group	Tissue-penetrating mesh-fixation	Patients who have undergone laparoscopic inguinal hernia repair with the use of tacks, staples or sutures for mesh fixation

Primary Outcome Measures

Name	Time	Method
Chronic pain	within period from one year after procedure until follow-up	Reported pain (questionnaire) from one year after procedure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark