Retrospective, Single Center Clinical Study on the Clinical Performance of Histoacryl® Lapfix - Cannula for Laparoscopic Inguinal Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 443
- 试验地点
- 2
- 主要终点
- Hernia recurrence rate
研究概览
简要总结
The goal of this retrospective study is to identify the incidence of hernia recurrence following the application of Histoacryl® Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery. All adult patients who underwent laparoscopic inguinal hernia repair with Histoacryl® Lapfix - Cannula in the period June 2018 - March 2021 at Hospital San Juan de Dios will be analysed. The investigator team will access electronical medical records for the cohort of patients identified.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult patients (≥18 years old)
- •treated between June 2018 and March 2021 at the Hospital San Juan de Dios for laparoscopic mesh fixation with Histoacryl Lapfix - Cannula after inguinal hernia repair surgery.
排除标准
- •No exclusion criteria has been set.
结局指标
主要结局
Hernia recurrence rate
时间窗: until 6 months postoperatively
Describe the incidence of hernia recurrence following the application of Histoacryl® LapFix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery. The incidence of hernia recurrence is documented from the medical records until 6 months postoperatively.
次要结局
- Delayed tissue adhesive polymerization(intraoperatively)
- Organ injury(intraoperatively)
- Mesh migration(at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months)
- Hematoma(at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months)
- Hemorrhage(at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months)
- Orchitis(at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months)
- Mesh repositioning or removal(until 6 months postoperatively)
- Intraoperative bleeding requiring therapeutic measures(intraoperatively)
- Erosion(at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months)
- Reintervention(until 6 months postoperatively)
- Adhesions(at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months)
- Tack hernias(at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months)
- Surgical Site Infection (superficial, deep, intraabdominal)(at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months)
- Acute or chronic pain(until 6 months postoperatively)
- Meshoma formation(at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months)
- Hernia recurrence(at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months)
- Seroma(at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months)
- Other Adverse Event(at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months)