Postoperative Pain, Ventral Hernia
Conditions
Keywords
surgical fixation devices, postoperative pain, ventral hernia, fibrin tissue adhesive, laparoscopy, quality of life, fatigue
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.
Interventions
PROCEDUREtack fixation of mesh
tack fixation of mesh
PROCEDUREglue fixation of mesh
glue fixation of mesh
Sponsors
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative pain VAS 0-100 mm | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| QoL, SF-36, recurrence (safety) | 1 year |
Countries
Denmark
Outcome results
None listed