Clinical trial NCT00842842: Mesh Fixation With Intraperitoneal Tisseel
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Ventral Hernia
Keywords: surgical fixation devices
postoperative pain
ventral hernia
fibrin tissue adhesive
laparoscopy
quality of life
fatigue
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2009-02-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain VAS 0-100 mm
timeFrame: 1 year
Secondary outcomes:
measure: QoL, SF-36, recurrence (safety)
timeFrame: 1 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg University Hospital, Dept. Surgical Gastroenterology
city: Gentofte, Copenhagen
country: Denmark
facility: Gentofte University Hospital, Dept. Surg. Gastroenterology
city: Herlev
country: Denmark
facility: Herlev University Hospital, Dept. Surgical Gastroenterology
city: Koege
country: Denmark
facility: Køge University Hospital, Dept. Surg. Gastroenterology
Study officials:
affiliation: Herlev University Hospital, Dept. Surg. Gastroenterology
name: Jacob Rosenberg, Professor, D.Sc
role: STUDY_CHAIR
References:
citation: Eriksen JR, Poornoroozy P, Jorgensen 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.
citation: 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.
citation: Eriksen JR, Gogenur I, Rosenberg J. Choice of mesh for laparoscopic ventral hernia repair. Hernia. 2007 Dec;11(6):481-92. doi: 10.1007/s10029-007-0282-8. Epub 2007 Sep 11.
citation: Eriksen JR, Bisgaard T, Assaadzadeh S, Jorgensen LN, Rosenberg J. Randomized clinical trial of fibrin sealant versus titanium tacks for mesh fixation in laparoscopic umbilical hernia repair. Br J Surg. 2011 Nov;98(11):1537-45. doi: 10.1002/bjs.7646. Epub 2011 Aug 24.