Clinical trial NCT03324854: Use of Mosquito Net Mesh for Ventral Hernia Repair
Official title: Use of Mosquito Net Mesh in Comparison With Polypropylene Mesh for Ventral Hernia Repair.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Ventral
Ventral Incisional Hernia
Keywords: Mosquito net
Mesh
Polypropylene mesh
Prolene mesh
ventral hernia
hernia
Lead sponsor: Hospital Central "Dr. Ignacio Morones Prieto"
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Recurrence
timeFrame: One year
Secondary outcomes:
measure: Infection
timeFrame: first week, 1 month, 3 month, 6 month and One year
measure: Seroma
timeFrame: first week, 1 month, 3 month, 6 month and One year
measure: length of hospital stay
timeFrame: Days
Other outcomes:
Locations:
Study officials:
affiliation: Universidad autonoma de san luis potosi
name: Jesus M Sanchez, MD
role: STUDY_DIRECTOR
References:
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