Surgical mesh repair of incisional and ventral hernias Digestive System Unspecified abdominal hernia
Conditions
Interventions
The patient will be divided in two groups according to the procedure they will undergo:
GROUP R (reconstruction)
Planned number of patients will be submitted to a Rives-Stoppa procedure for the repai
Sponsors
University of Genoa (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with a midline incisional or a ventral primitive hernia 2. Dimension measured on preoperative CT scan: 2.1. Primary ventral hernia ¡Ý4 d ¡Ü10 cm in its greatest diameter ¡°large¡± according to EHS classification) 2.2. Incisional hernias W2 according to EHS classification 3. Both sex 4. 60 years of age 5. BMI<35Kg/m2 6. Give informed consent for randomization
Exclusion criteria
Exclusion criteria: 1. Patients with non-midline defects or diastasis recti without herniation 2. Hernia with a previous attempt of mesh repair 3. Hernia is near to a bony salience 4. Patient is classified as American Society of Anesthesiologists class 4 or 5 5. Patient has a severe comorbid condition likely to limit survival to 2 years 6. Patient has cirrhosis with or without ascites 7. Patient is under immunosuppressive treatment has received previous bariatric surgery 8. Patient has bowel obstruction, strangulation, peritonitis, or perforation; 9. Presence of local or systemic infection 10. Neuromuscolar disease likely to impair motility (e.g. previous ictus with reliquate) 11. Patients refusing to participate to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative variations in double leg lowering test (DLL) at 6 and 12 months (as compared to preoperatory) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Differences in Trunk raising test (TR test) at 6 and 12 months 2. Differences in Abdominal Wall Strenght (AWS) score at 6 and 12 months 3. Differences in respiratory function tests at 6 and 12 months 4. Differences in intrabdominal pressure (IAP) pre and postoperative 5. Differences in pain assessed with Visual Analogue Scale (VAS) at 6 and 12 months 6. Differences in quality of life using SF-36 at 6 and 12 months | — |
Countries
Italy
Outcome results
None listed