Postoperative PainMEFIXITNCT00842842
Mesh Fixation With Intraperitoneal Tisseel
A study testing tack fixation of mesh and glue fixation of mesh in people with Postoperative Pain and Ventral Hernia, run by Herlev Hospital at 4 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pain, Ventral Hernia
- What is being tested?
- tack fixation of mesh and glue fixation of mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesDenmark
- Study dates
- Aug 2009to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-85 years and Danish speaking
- Umbilical hernia Ø 1.5 - 5 cm at preoperative clinical examination
- ASA group I-III
Who cannot join
- 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)
Show all 9Show fewer
- Pregnancy
- Other hernias recognized perop. and operated on at the same operation
- Lack of consent
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Bispebjerg University Hospital, Dept. Surgical Gastroenterology
Copenhagen
Gentofte University Hospital, Dept. Surg. Gastroenterology
Gentofte, Copenhagen, 2900
Herlev University Hospital, Dept. Surgical Gastroenterology
Herlev, 2730
Køge University Hospital, Dept. Surg. Gastroenterology
Koege, 4600
About this study
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
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.
- Conditions
- Postoperative Pain, Ventral Hernia
- Being tested
- tack fixation of mesh, glue fixation of mesh
- Keywords
- surgical fixation devices, postoperative pain, ventral hernia, fibrin tissue adhesive, laparoscopy, quality of life, fatigue
- Medical subject headings
- Pain, Postoperative, Hernia, Ventral, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tack fixation of meshProcedure or surgery
tack fixation of mesh
glue fixation of meshProcedure or surgery
glue fixation of mesh
| Study group | Role | What they receive |
|---|---|---|
| 1: tacks | Active comparator | mesh fixation with tacks Receives: Procedure: tack fixation of mesh |
| 2: glue | Experimental | mesh fixation with glue Receives: Procedure: glue fixation of mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain VAS 0-100 mm
Measured: 1 year
Secondary outcomes (1)
QoL, SF-36, recurrence (safety)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Ravn Eriksen, Herlev Hospital
- Investigators
- Jacob Rosenberg, Professor, D.Sc, Study chair, Herlev University Hospital, Dept. Surg. Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842842
- Sponsor's protocol ID
- H-B-2008-147
- Acronym
- MEFIXIT
- Status last verified
- Aug 2015
- First submitted
- 11 Feb 2009
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18670733Eriksen 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.
PubMed 18483783Eriksen 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.
PubMed 17846703Eriksen 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.
PubMed 21964681
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00842842
- Acronym / sponsor ID
- MEFIXIT / H-B-2008-147
- Conditions
- Postoperative Pain, Ventral Hernia
- Keywords
- surgical fixation devices, postoperative pain, ventral hernia, fibrin tissue adhesive, laparoscopy, quality of life, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 12 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: tacks | Active comparator | Procedure: tack fixation of meshmesh fixation with tacks |
| 2: glue | Experimental | Procedure: glue fixation of meshmesh fixation with glue |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18-85 years and Danish speaking
- Umbilical hernia Ø 1.5 - 5 cm at preoperative clinical examination
- ASA group I-III
Key exclusion criteria (9 listed)
- Former laparoscopic umbilical herniotomy
- Incarceration
- Drug/alcohol abuse/ongoing use of strong analgesic
- Bad compliance
- Liver disease Child-Pugh stage B/C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tack fixation of meshtack fixation of mesh | Procedure or surgery | 1: tacks |
| glue fixation of meshglue fixation of mesh | Procedure or surgery | 2: glue |
Primary outcome
Postoperative pain VAS 0-100 mm
Time frame: 1 year
1 secondary outcome
QoL, SF-36, recurrence (safety)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
- Background: PubMed 18670733Eriksen 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.
- Background: PubMed 18483783Eriksen 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.
- Background: PubMed 17846703Eriksen 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.
- Derived from this study: PubMed 21964681Eriksen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Rosenberg, Professor, D.Sc study chair
Herlev University Hospital, Dept. Surg. Gastroenterology
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tack fixation of mesh and glue fixation of mesh in people with Postoperative Pain and Ventral Hernia, run by Herlev Hospital at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain VAS 0-100 mm (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00842842, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015; AzTrials last refreshed its copy on 30 Oct 2026.