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Mesh Fixation With Intraperitoneal Tisseel (MEFIXIT)

This study has been completed.
Information provided by (Responsible Party):
Jens Ravn Eriksen, Herlev Hospital Identifier:
First received: February 11, 2009
Last updated: August 17, 2015
Last verified: August 2015
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 (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

Resource links provided by NLM:

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Postoperative pain VAS 0-100 mm [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • QoL, SF-36, recurrence (safety) [ Time Frame: 1 year ]

Enrollment: 40
Study Start Date: August 2009
Study Completion Date: July 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


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00842842

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
Study Chair: Jacob Rosenberg, Professor, D.Sc Herlev University Hospital, Dept. Surg. Gastroenterology
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jens Ravn Eriksen, MD PhD, Herlev Hospital Identifier: NCT00842842     History of Changes
Other Study ID Numbers: H-B-2008-147
Study First Received: February 11, 2009
Last Updated: August 17, 2015

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

Additional relevant MeSH terms:
Pain, Postoperative
Hernia, Ventral
Pathological Conditions, Anatomical
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Hernia, Abdominal
Fibrin Tissue Adhesive
Coagulants processed this record on April 26, 2017