Complications, Postoperative Pain, Recurrence
Conditions
Keywords
operation time, length of hospital stay
Brief summary
Primary closure of incisional hernia without the use of a mesh shows recurrence rates of up to 54%. If a mesh is used, the defect can be closed tension-free. Using this method, recurrence rates have been reduced to 8-21%. Laparoscopic correction of incisional hernia is a relatively new technique in which the mesh is positioned intraperitoneally. Research has shown that this procedure is technical feasible and may have benefits for the patients. The ongoing debate about the merits of endoscopic versus open incisional hernia repair prompts the need for a level 1 randomized controlled trial.
Interventions
PROCEDUREincisional hernia repair
Tension-free open or laparoscopic incisional hernia repair
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* hernia diameter between 3 and 15 cm * location at the ventral abdominal wall at least 5cm from costae and inguinal area * indication for elective repair * age of 18 years or older * written informed consent.
Exclusion criteria
* contraindication for pneumoperitoneum * an absolute contraindication for general anesthesia * history of open abdomen treatment * patients participating in other trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative pain | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| complications | 4 weeks |
| operation time | 1 day |
| Postoperative analgesics use | 1 week |
| recurrence | 5 years |
| mortality | 5 years |
| length of hospital stay | 4 weeks |
Outcome results
None listed