aparoscopic versus Open Ventral Hernia repair using a classical versus Collagen MESH (Surgisis Gold®): a European Multicenter Two Factorial Randomized Controlled Trial (LAPSIS Trial)

Individual Sponsor (Germany)0 个研究点目标入组 253 人开始时间: 2005年9月15日最近更新: 2021年1月5日

适应症

试验速览

•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

发起方

Individual Sponsor (Germany)