Skip to main content
OpenTrials
Completed

NCT Number: NCT00842842

Mesh Fixation With Intraperitoneal Tisseel

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Fatigue Hernia Hernia, Abdominal Hernia, Ventral Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Ventral Hernia

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg University Hospital, Dept. Surgical Gastroenterology, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tack fixation of mesh

Procedure

tack fixation of mesh

glue fixation of mesh

Procedure

glue fixation of mesh

Primary outcomes

  1. Postoperative pain VAS 0-100 mm

    Time frame: 1 year

Secondary outcomes

  1. QoL, SF-36, recurrence (safety)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study 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

Acronym: MEFIXIT

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Feb 12, 2009
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.