Use of Mosquito Net Mesh in Comparison With Polypropylene Mesh for Ventral Hernia Repair.
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Rate of Recurrence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
mosquito net mesh
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.
干预措施: Rives technique (Procedure)
mosquito net mesh
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.
干预措施: Drainage (Procedure)
mosquito net mesh
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.
干预措施: Prophylactic (Drug)
prolene mesh
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.
干预措施: Rives technique (Procedure)
prolene mesh
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.
干预措施: Drainage (Procedure)
prolene mesh
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.
干预措施: Prophylactic (Drug)
结局指标
主要结局
Rate of Recurrence
时间窗: One year
Rate of Reappearance of a ventral hernia post procedure after a year.
次要结局
- Infection(first week, 1 month, 3 month, 6 month and One year)
- Seroma(first week, 1 month, 3 month, 6 month and One year)
- length of hospital stay(Days)
研究者
David Esmer
Head of general surgery, Department of surgery
Hospital Central "Dr. Ignacio Morones Prieto"