Mesh Fixation With Intraperitoneal Tisseel

Postoperative Pain Clinical Trial

— MEFIXIT  

Official title:

A Prospective, Controlled, Randomized, Patient and Evaluator Blinded Study to Evaluate Pain and Recovery in Patients Undergoing Laparoscopic Umbilical Hernia Repair by Fixing the Mesh With Tisseel Versus Tackers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842842
• Other study ID #: H-B-2008-147
• Status: Completed
• Phase: N/A
• First received: February 11, 2009
• Last updated: August 17, 2015
• Start date: August 2009
• Est. completion date: July 2011

Study information

• Verified date: August 2015
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Pain, Postoperative
• Postoperative Pain
• Ventral Hernia

Intervention

Procedure:
• tack fixation of mesh
tack fixation of mesh
• glue fixation of mesh
glue fixation of mesh

Locations

Country	Name	City	State
Denmark	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

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Eriksen JR, Bech JI, Linnemann D, Rosenberg J. Laparoscopic intraperitoneal mesh fixation with fibrin sealant (Tisseel) vs. titanium tacks: a randomised controlled experimental study in pigs. Hernia. 2008 Oct;12(5):483-91. doi: 10.1007/s10029-008-0375-z. Epub 2008 May 16. — View Citation

Eriksen JR, Gögenur I, Rosenberg J. Choice of mesh for laparoscopic ventral hernia repair. Hernia. 2007 Dec;11(6):481-92. Epub 2007 Sep 11. Review. — View Citation

Eriksen JR, Poornoroozy P, Jørgensen LN, Jacobsen B, Friis-Andersen HU, Rosenberg J. Pain, quality of life and recovery after laparoscopic ventral hernia repair. Hernia. 2009 Feb;13(1):13-21. doi: 10.1007/s10029-008-0414-9. Epub 2008 Aug 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain VAS 0-100 mm		1 year	No
Secondary	QoL, SF-36, recurrence (safety)		1 year	No