Mesh Fixation With Intraperitoneal Tisseel

Not Applicable

Completed

• Conditions: Ventral Hernia; Postoperative Pain
• Interventions: Procedure: tack fixation of mesh; Procedure: glue fixation of mesh

• Registration Number: NCT00842842
• Lead Sponsor: Herlev Hospital

Brief Summary

The purpose of this study is to determine whether mesh fixation in laparoscopic umbilical hernia repair with fibrin glue is superior to tacks in terms of postoperative pain and recovery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-11
• Study First Submitted QC: 2009-02-11
• Study First Posted: 2009-02-12
• Study Start: 2009-08
• Primary Completion: 2010-06
• Study Completion: 2011-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age: 18-85 years and Danish speaking
• Umbilical hernia Ø 1.5 - 5 cm at preoperative clinical examination
• ASA group I-III

Exclusion Criteria

• Former laparoscopic umbilical herniotomy
• Incarceration
• Drug/alcohol abuse/ongoing use of strong analgesic
• Bad compliance
• Liver disease Child-Pugh stage B/C
• Immunodeficiency (ex. steroid use)
• Pregnancy
• Other hernias recognized perop. and operated on at the same operation
• Lack of consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: tacks	tack fixation of mesh	mesh fixation with tacks
2: glue	glue fixation of mesh	mesh fixation with glue

Primary Outcome Measures

Name	Time	Method
Postoperative pain VAS 0-100 mm	1 year

Secondary Outcome Measures

Name	Time	Method
QoL, SF-36, recurrence (safety)	1 year

Trial Locations

Locations (4)

Bispebjerg University Hospital, Dept. Surgical Gastroenterology; 🇩🇰 Copenhagen, Denmark

Gentofte University Hospital, Dept. Surg. Gastroenterology; 🇩🇰 Gentofte, Copenhagen, Denmark

Herlev University Hospital, Dept. Surgical Gastroenterology; 🇩🇰 Herlev, Denmark

Køge University Hospital, Dept. Surg. Gastroenterology; 🇩🇰 Koege, Denmark