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Mesh Fixation With Intraperitoneal Tisseel (MEFIXIT)

Primary Purpose

Postoperative Pain, Ventral Hernia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
tack fixation of mesh
glue fixation of mesh
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring surgical fixation devices, postoperative pain, ventral hernia, fibrin tissue adhesive, laparoscopy, quality of life, fatigue

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bispebjerg University Hospital, Dept. Surgical Gastroenterology
  • Gentofte University Hospital, Dept. Surg. Gastroenterology
  • Herlev University Hospital, Dept. Surgical Gastroenterology
  • Køge University Hospital, Dept. Surg. Gastroenterology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1: tacks

2: glue

Arm Description

mesh fixation with tacks

mesh fixation with glue

Outcomes

Primary Outcome Measures

Postoperative pain VAS 0-100 mm

Secondary Outcome Measures

QoL, SF-36, recurrence (safety)

Full Information

First Posted
February 11, 2009
Last Updated
August 17, 2015
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00842842
Brief Title
Mesh Fixation With Intraperitoneal Tisseel
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Ventral Hernia
Keywords
surgical fixation devices, postoperative pain, ventral hernia, fibrin tissue adhesive, laparoscopy, quality of life, fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: tacks
Arm Type
Active Comparator
Arm Description
mesh fixation with tacks
Arm Title
2: glue
Arm Type
Experimental
Arm Description
mesh fixation with glue
Intervention Type
Procedure
Intervention Name(s)
tack fixation of mesh
Intervention Description
tack fixation of mesh
Intervention Type
Procedure
Intervention Name(s)
glue fixation of mesh
Intervention Description
glue fixation of mesh
Primary Outcome Measure Information:
Title
Postoperative pain VAS 0-100 mm
Time Frame
1 year
Secondary Outcome Measure Information:
Title
QoL, SF-36, recurrence (safety)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Rosenberg, Professor, D.Sc
Organizational Affiliation
Herlev University Hospital, Dept. Surg. Gastroenterology
Official's Role
Study Chair
Facility Information:
Facility Name
Bispebjerg University Hospital, Dept. Surgical Gastroenterology
City
Copenhagen
Country
Denmark
Facility Name
Gentofte University Hospital, Dept. Surg. Gastroenterology
City
Gentofte, Copenhagen
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Herlev University Hospital, Dept. Surgical Gastroenterology
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Køge University Hospital, Dept. Surg. Gastroenterology
City
Koege
ZIP/Postal Code
4600
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
18670733
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.
Results Reference
background
PubMed Identifier
18483783
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.
Results Reference
background
PubMed Identifier
17846703
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.
Results Reference
background
PubMed Identifier
21964681
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.
Results Reference
derived

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Mesh Fixation With Intraperitoneal Tisseel

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