Inguinal Hernia, Femoral Hernia
Conditions
Keywords
Tapp, Early pain, well-being, Seroma, Haematoma, Fibrin glue, tacks
Brief summary
In this study the researchers want to compare fibrin glue versus tacked fixation in fixation of the mesh in laparoscopic groin hernia repair. The primary endpoints are early pain in the first 3 days postoperative days. Moreover, the researchers investigate general well-being, fatigue, seroma, haematoma, postoperative nausea and vomiting. Thirdly, they are investigating chronic pain and clinical recurrence.
Interventions
PROCEDUREFibrin glue
Tissucol 2 ml
PROCEDURETacks
Protacks
Sponsors
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* unilateral groin hernia * planned laparoscopic inguinal or femoral herniorrhaphy * ASA I-III * fluent Danish
Exclusion criteria
* converting to open operation * low compliance * daily use of morphine or similar drugs daily in the last month * complications to the operation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early pain after operation | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| seroma in groin region | day 10 |
| fatigue | 10 days |
| haematoma in groin region | day 10 |
| Postoperative nausea and vomiting (PONV) | 10 days |
| Use of Analgesics at PACU | 1 day |
| discomfort | 6 month |
Countries
Denmark
Outcome results
None listed