MEFIXIT: Mesh Fixation With Intraperitoneal Tisseel
Sponsor
Herlev Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00842842
Collaborator
(none)
40
4
2
23
10
0.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date
:
Aug 1, 2009
Actual Primary Completion Date
:
Jun 1, 2010
Actual Study Completion Date
:
Jul 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1: tacks mesh fixation with tacks |
Procedure: tack fixation of mesh
tack fixation of mesh
|
| Experimental: 2: glue mesh fixation with glue |
Procedure: glue fixation of mesh
glue fixation of mesh
|
Outcome Measures
Primary Outcome Measures
- Postoperative pain VAS 0-100 mm [1 year]
Secondary Outcome Measures
- QoL, SF-36, recurrence (safety) [1 year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bispebjerg University Hospital, Dept. Surgical Gastroenterology | Copenhagen | Denmark | ||
| 2 | Gentofte University Hospital, Dept. Surg. Gastroenterology | Gentofte, Copenhagen | Denmark | 2900 | |
| 3 | Herlev University Hospital, Dept. Surgical Gastroenterology | Herlev | Denmark | 2730 | |
| 4 | Køge University Hospital, Dept. Surg. Gastroenterology | Koege | Denmark | 4600 |
Sponsors and Collaborators
- Herlev Hospital
Investigators
- Study Chair: Jacob Rosenberg, Professor, D.Sc, Herlev University Hospital, Dept. Surg. Gastroenterology
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
Responsible Party:
Jens Ravn Eriksen,
MD PhD,
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00842842
Other Study ID Numbers:
- H-B-2008-147
First Posted:
Feb 12, 2009
Last Update Posted:
Aug 19, 2015
Last Verified:
Aug 1, 2015
Keywords provided by Jens Ravn Eriksen,
MD PhD,
Herlev Hospital
Additional relevant MeSH terms: