Laparoscopic Ventral Hernia Repair in Obese Patients: Safe and Effective Use of a Hybrid (PTFE / Biosynthetic) Mesh. Results of a Multicentric Prospective Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Rate of Incisional Hernia at Clinical examination
研究概览
简要总结
The aim of this study is to evaluate safety and effectiveness of a hybrid mesh (GORE® SYNECOR Intraperitoneal Biomaterial) in patients with a BMI of 30 kg/m2 or more undergoing laparoscopic ventral hernia repair (LVHR) with intraperitoneal position of the mesh.
详细描述
A prospective Italian multicenter observational trial will be conducted in 8 different Italian centers to compare the effectiveness and feasibility of treatment of Incisional Hernia with GORE® SYNECOR Intraperitoneal Biomaterial mesh in patients with BMI >30 kg/m2. This study was reviewed and approved by the local regional Ethics Committee. The study adhered to the CONSORT guidelines in reporting this trial's results
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •Clean wounds
- •Informed consent
- •Patients affected by Incisional and Ventral Hernia
- •Elective surgery
- •Hernia size between 3 e 7 cm
- •BMI > 30 kg/m2
排除标准
- •age < 18 years;
- •Life expectancy < 24 months (as estimated by the operating surgeon), -
- •Pregnancy
- •Immunosuppressant therapy within 2 weeks before surgery
- •Clean-contaminated and contaminated, dirty wounds
- •Cirrhosis
结局指标
主要结局
Rate of Incisional Hernia at Clinical examination
时间窗: Patients are postoperatively examined at 36 months.
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated
Rate of Incisional Hernia at ultrasonographic examination
时间窗: Patients are postoperatively examined at 36 months.
An abdominal ultrasonography with the patient lying prone, will be performed in in all patients (symptomatic or asymptomatic) providing any valuable information about Hernia Recurrence onset. Valsalva maneuver will be performed during the ultrasonography scan. Size and location of all imaging detected Hernia Recurrence will be recorded, as well as any other patient's complaint.
次要结局
- Number of patients affected by Deep surgical site infections(Within 30 days postoperatively)
- Number of patients affected by Superficial surgical site infections(Within 30 days postoperatively)
- Number of patients affected by organ space infections(Within 30 days postoperatively)
- Number of patients affected by Surgical Site Occurence(Within 30 days postoperatively)
- Postoperative pain(Postoperative pain will be recorded according to visual analogue scale at 24 months.)
研究者
Francesco Pizza
PhD, Md
Azienda Sanitaria Locale Napoli 2 Nord