Laparoscopic Versus Open Incisional Hernia Repair
Phase 3
Completed
- Conditions
- Postoperative PainComplicationsRecurrence
- Interventions
- Procedure: incisional hernia repair
- Registration Number
- NCT01420757
- Lead Sponsor
- Erasmus Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 206
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description open incisional hernia repair open incisional hernia repair laparoscopic incisional hernia repair laparoscopic incisional hernia repair
- Primary Outcome Measures
Name Time Method Postoperative pain 4 weeks
- Secondary Outcome Measures
Name Time Method Postoperative analgesics use 1 week complications 4 weeks operation time 1 day length of hospital stay 4 weeks recurrence 5 years mortality 5 years