Hernia, Ventral, Ventral Incisional Hernia
Conditions
Keywords
Mosquito net, Mesh, Polypropylene mesh, Prolene mesh, ventral hernia, hernia
Brief summary
It´s a pilot study, randomized, realized in the Central Hospital Dr. Ignacio Morones Prieto, SLP, Mexico. Hypothesis: The polyethylene mesh is secure in open ventral repair.
Detailed description
It´s a pilot study, randomized, realized in the Central Hospital Dr. Ignacio Morones Prieto, SLP, Mexico. The simple size for pilot study was been calculated in 20 patients, according with Browne for not knowing the variability of the treatment. 10 patients in the group of Polypropylene mesh (Prolene ®), braided monofilament thread, macropore, weight of 108.1 g/m2, fibres diameter of 0.53 mm, tensile force of 156.6 N/cm, with a pore of 1.6 mm2, in different size of 15 x 15 cm, 20 x 20 cm and 30 x 30 cm, and 10 patients in the group of mesh of PEBD (mosquito net), braided monofilament thread, macropore, ,weight of 53.7 g/m2, fibers diameter of 0.48 mm, tensile force of 42.7 N/cm and pore of 1.8 mm2, in different size 15 x 15 cm, 20 x 20 cm and 30x 30 cm donated by Dr. Ravindranath R. Tongaonkar. The sterilization were done in ethylene oxide. The randomisation for allocation the type of mesh for each patient was realized with numbers generated by computer with the program R version 3.0.2 with the simple function. The statistical analysis was carried out by the programs: JMP 8 (SAS Institute Inc., Cary, NC, USA) and R 2.15.1 23. The ventral hernia repair were carried out with standardized technique, placed the mesh int the preperitoneal or retromuscular space fixing with 2-0 poplypropylene suture and le fe active-close drainage, 30 minutes before the incision, prophylactic antibiotic 1gm of cefalotin was administered, in both groups, the patient was discharge at the first postoperatory day with drainage and retired at the first review at 1 week and recited at one, three, six and twelve months for reviewer. The descriptive analysis of categorical variables was expressed with frequencies and percentages; the numerical ones with normal distribution in averages and standard deviation, the variables with distribution not normal with medians and status (maximum and minimal values). The values of p\<0.05 were considered to be significant. This study was evaluated and accepted by the Committee of Investigation and the Committee of Ethics, with number of record 42-17.
Interventions
PROCEDURERives technique
Open ventral hernia repair followed by the placement of the mesh.
PROCEDUREDrainage
Placement of active-close drainage in surgical site.
DRUGProphylactic
Prophylactic antibiotic 1gm of cefalotin was administered 30 minutes before the incisión.
Sponsors
Hospital Central Dr. Ignacio Morones Prieto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The randomisation for allocation the type of mesh for each patient was realized with numbers generated by computer with the program R version 3.0.2 with the simple function. The participant and the outcomes assessor did not know the type of mesh.
Intervention model description
The simple size for pilot study was been calculated in 20 patients, according with Browne for not knowing the variability of the treatment. 10 patients in the group of Polypropylene mesh (Prolene ®) and , and 10 patients in the group of mesh of PEBD (mosquito net).
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* All the patients with primary or incisional elective ventral hernia repair with mesh were included, with ASA I,II and III between 18 and 75 years, of any sex, and that they accepted to take part in the protocol and signed the informed assent.
Exclusion criteria
* We excluded patients with incarcerated, strangulated hernia, signs of intestinal obstruction, consumption of anticoagulants, IMC \>35, parastomal hernias, hernia repair with intestinal reconnections at the same procedure or presented infection in abdominal wall.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Recurrence | One year | Rate of Reappearance of a ventral hernia post procedure after a year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection | first week, 1 month, 3 month, 6 month and One year | Number of participants with open ventral hernia repair that have adverse events as infection post procedure determined by clinical, leukocytosis and positive bacterial culture. |
| Seroma | first week, 1 month, 3 month, 6 month and One year | A seroma is a collection of fluid that builds up under the surface of your skin. |
| length of hospital stay | Days | the average number of days that patients spend in hospital. |
Outcome results
None listed