aparoscopic versus Open Ventral Hernia repair using a classical versus Collagen MESH (Surgisis Gold®): a European Multicenter Two Factorial Randomized Controlled Trial (LAPSIS Trial)
- Conditions
- Primary or incisional ventral herniaSurgeryVentral hernia
- Registration Number
- ISRCTN34532248
- Lead Sponsor
- Individual Sponsor (Germany)
- Brief Summary
2021 results in https://pubmed.ncbi.nlm.nih.gov/33332873/ (added 18/12/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- Not specified
- Target Recruitment
- 253
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major complication (hernia recurrence, prosthetic infection, re-operation) rate within three years after surgery
- Secondary Outcome Measures
Name Time Method <br> 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)<br> 2. Early (first 30 days postoperatively) general complication rate (all adverse events other than listed under local complications: thromboembolic events, cardiac, respiratory, other)<br> 3. Time to failure (= major complication)<br> 4. Chronic abdominal wall pain (Von Korff chronic pain questionnaire; preoperatively, one and three years postoperatively<br> 5. Chronic discomfort e.g. abdominal wall stiffness (visual analogue scale [VAS]; preoperatively and three years postoperatively)<br> 6. Mortality (up to three years postoperatively)<br> 7. Incidence of and cause for conversion in the laparoscopy group<br>