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Mesh Fixation With Intraperitoneal Tisseel (MEFIXIT)

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ClinicalTrials.gov Identifier: NCT00842842
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Jens Ravn Eriksen, Herlev Hospital

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
Postoperative Pain Ventral Hernia Procedure: tack fixation of mesh Procedure: glue fixation of mesh Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : August 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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




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

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


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jens Ravn Eriksen, MD PhD, Herlev Hospital
ClinicalTrials.gov Identifier: NCT00842842     History of Changes
Other Study ID Numbers: H-B-2008-147
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015

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

Additional relevant MeSH terms:
Pain, Postoperative
Hernia
Hernia, Ventral
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pathological Conditions, Anatomical
Hernia, Abdominal
Fibrin Tissue Adhesive
Hemostatics
Coagulants