Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: LAPAROSCOPIC VENTRAL HERNIA REPAIR BY LIGHTWEIGHT POLYPROPYLENE MESH. A PROSPECTIVE ITALIAN MULTICENTRIC RANDOMIZED STUDY COMPARING TWO FIXATION DEVICES: TITANIUM SPIRAL TACKS vs ABSORBABLE TACKS
Brief Summary: Background: Laparoscopic repair of ventral hernias has gained popularity, since many studies and a recent meta-analysis have reported encouraging results and recurrence rates similar to open repair. The choice of the mesh and fixation methods is of paramount importance during laparoscopic approach, and nowadays, lightweight macropore meshes specifically designed for laparoscopic approach represent the first choice in several studies, due to the biomechanical properties and the optimal integration into the abdominal wall. No data with statistical relevance exist on the choice of fixation methods.

Primary end point of the present Italian multicentric prospective randomized trial is to evaluate the safety and effectiveness of two different tacks to fix the lightweight polypropylene mesh (Physiomesh™) during laparoscopic incisional hernia repair: metallic spiral tacks (Protack™) vs absorbable "U" shaped tacks (Securestrap™)

Design of the Study: 200 patients with ventral hernia will be randomized into two groups:

Group A patients will be submitted to laparoscopic repair by Physiomesh fixed by Protack; Group B patients will be submitted to laparoscopic repair by Physiomesh fixed by Securestrap.

Blind randomization will be guaranteed by an on-line software with specific key access for every surgical unit participating in the study. Patients demographics and characteristics, preoperative studies, intraoperative and postoperative results and complications, as well as scheduled follow-up will be recorded and uploaded to the database. Data represented by continuous variables will be expressed as arithmetic mean +/- standard deviation. Other data will be expressed as geometric mean +/- 95% confidence interval. Data representing low incidence events will be expressed as number and percentage of occurrence for each group. Statistical significance for all analyses will be indicated by a p value of 0.05 or less.


Options:
A: Arm Label: fixation with Protack; Type: EXPERIMENTAL; Interventions: Procedure: laparoscopic ventral herniotomy, Device: Protack | Arm Label: fixation with Securestrap; Type: EXPERIMENTAL; Interventions: Procedure: laparoscopic ventral herniotomy, Device: Securestrap | Arm Label: fixation with Glubran; Type: EXPERIMENTAL; Interventions: Procedure: laparoscopic ventral herniotomy, Device: Glubran | Intervention Type: PROCEDURE; Name: laparoscopic ventral herniotomy; Assigned to Arm(s): fixation with Glubran, fixation with Protack, fixation with Securestrap | Intervention Type: DEVICE; Name: Protack; Assigned to Arm(s): fixation with Protack | Intervention Type: DEVICE; Name: Securestrap; Assigned to Arm(s): fixation with Securestrap | Intervention Type: DEVICE; Name: Glubran; Assigned to Arm(s): fixation with Glubran
B: Arm Label: Group A; Type: OTHER; Interventions: Procedure: Laparoscopic incisional or ventral hernia repair | Arm Label: Group B; Type: OTHER; Interventions: Procedure: Laparoscopic incisional or ventral hernia repair | Intervention Type: PROCEDURE; Name: Laparoscopic incisional or ventral hernia repair; Assigned to Arm(s): Group A, Group B
C: Arm Label: small hernias - suture repair; Type: ACTIVE_COMPARATOR; Interventions: Procedure: abdominal wall reconstruction | Arm Label: small hernias - mesh repair; Type: ACTIVE_COMPARATOR; Interventions: Procedure: abdominal wall reconstruction | Arm Label: large hernias - sublay mesh; Type: ACTIVE_COMPARATOR; Interventions: Procedure: abdominal wall reconstruction | Arm Label: large hernias - onlay mesh; Type: ACTIVE_COMPARATOR; Interventions: Procedure: abdominal wall reconstruction | Intervention Type: PROCEDURE; Name: abdominal wall reconstruction; Assigned to Arm(s): large hernias - onlay mesh, large hernias - sublay mesh, small hernias - mesh repair, small hernias - suture repair
D: Intervention Type: PROCEDURE; Name: Retromuscular Mesh repair of midline incisional hernia; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: Laparoscopic repair of midline incisional hernia; Assigned to Arm(s): N/A

Answer: B