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

Herlev Hospital

Status: Completed

Conditions: Hernia, Inguinal; Chronic Pain; Recurrence

Treatments: Procedure: Fibrin Sealant; Procedure: Tissue-penetrating mesh-fixation

Study type: Observational

Funder types: Other

Identifiers

NCT01597011

BS12-000733

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,340 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

inguinal hernia repair from January 2009-September 2012

Exclusion criteria

Patients lost to follow-up

Trial design

2,340 participants in 2 patient groups

Fibrin sealant group

Description:

Patients who have undergone laparoscopic inguinal hernia repair with fibrin sealant for mesh fixation

Treatment:

Procedure: Fibrin Sealant

Tissue-penetrating fixation group

Description:

Patients who have undergone laparoscopic inguinal hernia repair with the use of tacks, staples or sutures for mesh fixation

Treatment:

Procedure: Tissue-penetrating mesh-fixation