Aparoscopic Bridging vs anatomic Open Reconstruction for midline abdominal hernia mesh repair

Completed

Conditions: Surgical mesh repair of incisional and ventral hernias
Digestive System
Unspecified abdominal hernia

Registration Number: ISRCTN93729016

Lead Sponsor: niversity of Genoa (Italy)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative variations in double leg lowering test (DLL) at 6 and 12 months (as compared to preoperatory)

Secondary Outcome Measures

Name	Time	Method
1. Differences in Trunk raising test (TR test) at 6 and 12 months <br>2. Differences in Abdominal Wall Strenght (AWS) score at 6 and 12 months <br>3. Differences in respiratory function tests at 6 and 12 months <br>4. Differences in intrabdominal pressure (IAP) pre and postoperative <br>5. Differences in pain assessed with Visual Analogue Scale (VAS) at 6 and 12 months <br>6. Differences in quality of life using SF-36 at 6 and 12 months