Primary or incisional ventral hernia Surgery Ventral hernia
Conditions
Interventions
Collagen mesh (Surgisis Gold® [perforated]) versus conventional mesh and laparoscopic versus open ventral hernia repair.
Updated 10/09/2009: this trial has stopped recruiting and the
Sponsors
Individual Sponsor (Germany)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Elective repair of ventral (including umbilical) hernia with need for mesh repair 2. Age =18 years 3. Male and female patients may participate 4. Minimal hernia orifice diameter =4 cm 5. Largest hernia orifice =10 cm 6. Eligibility to laparoscopic mesh repair 7. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Medical or surgical contraindication to general anesthesia 2. Severe comorbidity (American Society of Anesthesiologists [ASA] physical status classification =4) 3. Pregnancy 4. Emergency surgery for incarcerated irreducible hernia 5. Previous mesh repair at the same site 6. Hernia orifice <3 cm away from costal margin/sternum and/or pubis 7. Lumbar hernia 8. Parastomal hernia 9. Need for more than one mesh covering the hernia orifice 10. Need for a mesh larger than 20 cm x 20 cm or 22 cm x 13 cm 11. Crohn?s disease 12. Life expectancy less than 12 months 13. Chemotherapy within the last four weeks 14. Radiotherapy within the last two months 15. Previous abdominal radiotherapy 16. Known allergy against porcine materials 17. Marfan?s syndrome 18. Child B or C liver disease 19. Morbid obesity (body mass index [BMI] =40 kg/m^2) 20. Non-compliance 21. Simultaneous participation in other interventional trials interfering with one of the approaches in this trial 22. Previous participation in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major complication (hernia recurrence, prosthetic infection, re-operation) rate within three years after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Early (first 30 days postoperatively) and late (up to three years postoperatively) local complication rate (wound infection, wound dehiscence, wound sinus, fistula formation, bleeding, hematoma, seroma formation, peritonitis, mechanical obstruction, ileus, other) 2. Early (first 30 days postoperatively) general complication rate (all adverse events other than listed under local complications: thromboembolic events, cardiac, respiratory, other) 3. Time to failure (= major complication) 4. Chronic abdominal wall pain (Von Korff chronic pain questionnaire; preoperatively, one and three years postoperatively 5. Chronic discomfort e.g. abdominal wall stiffness (visual analogue scale [VAS]; preoperatively and three years postoperatively) 6. Mortality (up to three years postoperatively) 7. Incidence of and cause for conversion in the laparoscopy group | — |
Countries
Austria, Belgium, Croatia, Denmark, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal
Outcome results
None listed