Use of Mosquito Net Mesh for Ventral Hernia Repair

Not Applicable

• Conditions: Hernia, Ventral; Ventral Incisional Hernia
• Interventions: Procedure: Rives technique; Procedure: Drainage; Drug: Prophylactic

• Registration Number: NCT03324854
• Lead Sponsor: Hospital Central "Dr. Ignacio Morones Prieto"

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.

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-26
• Primary Completion: 2017-10-30
• Study First Posted: 2017-10-30
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-11-09
• Study Completion: 2018-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mosquito net mesh	Rives technique	The open ventral hernia repair were carried out with rives technique, followed by the placement of the mosquito net mesh, and left active-close drainage, 30 minutes before the incisión, prophylactic antibiotic 1gm of cefalotin was administered.
mosquito net mesh	Drainage	The open ventral hernia repair were carried out with rives technique, followed by the placement of the mosquito net mesh, and left active-close drainage, 30 minutes before the incisión, prophylactic antibiotic 1gm of cefalotin was administered.
prolene mesh	Rives technique	The open ventral hernia repair were carried out with rives technique, followed by the placement of the prolene mesh, and left active-close drainage, 30 minutes before the incisión, prophylactic antibiotic 1gm of cefalotin was administered.
prolene mesh	Drainage	The open ventral hernia repair were carried out with rives technique, followed by the placement of the prolene mesh, and left active-close drainage, 30 minutes before the incisión, prophylactic antibiotic 1gm of cefalotin was administered.
mosquito net mesh	Prophylactic	The open ventral hernia repair were carried out with rives technique, followed by the placement of the mosquito net mesh, and left active-close drainage, 30 minutes before the incisión, prophylactic antibiotic 1gm of cefalotin was administered.
prolene mesh	Prophylactic	The open ventral hernia repair were carried out with rives technique, followed by the placement of the prolene mesh, and left active-close drainage, 30 minutes before the incisión, prophylactic antibiotic 1gm of cefalotin was administered.

Primary Outcome Measures

Name	Time	Method
Rate of Recurrence	One year	Rate of Reappearance of a ventral hernia post procedure after a year.

Secondary Outcome Measures

Name	Time	Method
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.