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Mesh Fixation With Intraperitoneal Tisseel (MEFIXIT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Herlev Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00842842
First received: February 11, 2009
Last updated: August 18, 2010
Last verified: August 2010
History of Changes
  Purpose

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 Intervention
Postoperative Pain
Ventral Hernia
 Procedure: tack fixation of mesh
Procedure: glue fixation of mesh

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Postoperative pain VAS 0-100 mm [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • QoL, SF-36, recurrence (safety) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2009
Estimated Study Completion Date: May 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842842

Locations
Denmark
Bispebjerg University Hospital, Dept. Surgical Gastroenterology
Copenhagen, Denmark
Gentofte University Hospital, Dept. Surg. Gastroenterology
Gentofte, Copenhagen, Denmark, 2900
Herlev University Hospital, Dept. Surgical Gastroenterology
Herlev, Denmark, 2730
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jens Ravn Eriksen, MD, Herlev Hospital, Dept. of surgical gastroenterology
ClinicalTrials.gov Identifier: NCT00842842     History of Changes
Other Study ID Numbers: H-B-2008-147
Study First Received: February 11, 2009
Last Updated: August 18, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Herlev Hospital:
surgical fixation devices
postoperative pain
ventral hernia
fibrin tissue adhesive
 laparoscopy
quality of life
fatigue

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pain, Postoperative
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes
Pain
 Signs and Symptoms
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013