Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of Peri-operative and Post-operative Complications
研究概览
简要总结
The aim of this Observational Registry Study is to assess the short- and long-term clinical outcomes following the use of Symbotex™ Composite Mesh in primary and incisional abdominal wall hernia surgeries by open or laparoscopic approach, according to the Instruction for use (IFU).
详细描述
This is an observational multicenter registry study. One hundred consecutive, adult patients scheduled for primary and incisional abdominal wall hernia surgeries using Symbotex™ Composite Mesh will be reported in the ClubHernie online database, with standard data captured of all preoperative, perioperative and post-operative data, for patient's outcomes measurements.
Primary Objective:
Evaluate the incidence of peri-operative and post-operative complications, with postoperative evaluations occurring, at discharge , 1 week (D1 and D8 follow up), 1 month (D30 follow up), 1 year and 2 year follow up after primary and incisional abdominal wall hernia surgeries using Symbotex™ Composite Mesh by open or laparoscopic approach (such as anticipated device related complications such as pain, recurrence, complications related to adhesions, wound complications, other postoperative complications, (SAE).
This online database consists of a systematic and consecutive data entry of all patients treated for Inguinal Hernia and Ventral Hernia by the 30 French surgeon members, with standard data captured of all preoperative, perioperative and post-operative data.
The database is required to be completed anonymously. Quality data control of all data captured into the online database will be performed by coherence analysis by Club Hernie authorized representative;A statistical analysis plan will be developed by Covidien.
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
- •The first one hundred consecutive adult patients scheduled for primary and incisional abdominal wall hernia surgery by Club Hernie members surgeons using Symbotex™Composite Mesh ;- All patients regardless of gender ≥ 18 years of age presenting with ventral hernias.
- •Patients will be informed by surgeon with a written information notice of the nature of the observational registry study.
排除标准
- •No exclusion criteria outside the product IFU
结局指标
主要结局
Incidence of Peri-operative and Post-operative Complications
时间窗: Various (measured at 1 month, 1 Year & 2 Year)
Primary endpoint focuses on complications (including recurrence) occurring during procedure, and in short, mid and long-term (measured at 1 month, 1 year and 2 year follow-up respectively) following ventral hernia repair. All peri-, intra- and post- operative complications
次要结局
- The Use of Symbotex™ Composite Mesh and Surgery Duration(Baseline Day 0)
- The Use of Symbotex™ Composite Mesh and Hospital Stay Duration(Baseline Day 0)
- Quality of Life for Patient(Various ( 1 Month, 1 year and 2 Year follow up))
- Patient Satisfaction(Various (1 year and 2 year))
- Pain Assessment Measured With VAS Score(Various ( Baseline Day 0, Day 1, Day 8, Month 1, Month 3, 1 year , 2 year)
- Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use)(Day 0 Baseline)
- Mesh Handling(Day 0 Baseline)
- The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair(Baseline Day 0)