Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* ventral hernia 2(1,5) \< dia \> 7 cm
* danish speaking
* of sound mind
* bmi \< 35
* ASA 3 or less, no contra indication against laparoscopy

Exclusion Criteria:

* other size hernias,
* no danish,
* bmi \> 35
B: Inclusion Criteria:

Table 1: Inclusion criteria Hernia site\*

* M2
* M3
* M4
* L2
* L3 Hernia width\*
* W1
* W2
* No previous vnetral/incisional hernia repair (R0)\*
* No incarcerated/strangulated hernia
* No contaminated field or bowel resection during repair
* BMI \< 35
* Age between 18 and 75 years old
* No severe COPD
* No autoimmune disease under corticosteroids treatment
* No cirrhosis Child B or C
* No uncontrolled diabetic (Glycated Hemoglobin \< 7)

  * According to: Muysoms FE, et al. Classification of primary and incisional abdominal wall hernias: Hernia 2009; 13: 407-414

Exclusion Criteria:

-
C: Inclusion Criteria:

* During the two-year randomization period at the joined centres all patients were included who were admitted with abdominal wall or umbilical hernia and who suited the requirements.
* All the patients with primer or first recurrence of postoperative abdominal or primer or first recurrence of umbilical hernia were randomized into this study.
* For involvement into the study good patient compliance, signed consent form, normal local circumstances were needed.

Exclusion Criteria:

* Ages fewer than 18 or above 70 years
* Hernia orifice under 5 cm2.
* Planned or accidental intraoperative opening of any bowel.
* Unstable parameters of circulation, uncontrollable diabetic or autoimmune disease.
* Severe renal or hepatic failure
* Advanced stage of tumours or currently treated malignancies.
* Inflamed or muddy content of hernia sac.
* If the patient did not signed the consent form.
D: Inclusion Criteria:

* Age over 18 years
* Postoperative hernias in the region of the recti abdomini muscles with a defect of less than 10 cm transversal width
* No contraindications to laparoscopic procedure
* The patient should be able to adequate ventilation/respiration after reduction of hernia contents
* Indications for elective surgery

Exclusion Criteria:

* Pregnant women
* Prior operation of abdominal hernia with mesh placement in the compartment of the rectus abdominus muscle (i.e. prior onlay mesh is acceptable)
* Need of an interpreter
* Current drug abuse, mental disorder or other condition which makes the patient incapable of postoperative follow up
* Body Mass index (BMI) \>40
* Other planned concurrent operation
* Current oral steroid treatment, or other immune system modulating treatment
* Incarcerated incisional hernias
* Parastomal hernias
* Prior history of open abdomen
* Enterocutaneous fistula or cutaneous infection
* Hepatic cirrhosis or ascites
* Generalized malignancy
* History of radiation treatment in the abdomen.
* ASA \>III

Answer: B