Effect of the "O-ring" Technique in Reducing Cerebrospinal Fluid Leak in Posterior Fossa Surgery: an Explorative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- to estimate incidence of postoperative CSF leakage
研究概览
简要总结
Posterior fossa surgery represents on of the most demanding procedure in neurosurgery. Retrosygmoid (RS), key-hole retrosygmoid (KR) and cerebellar hemispheric (CH) are the most common approaches used to access in this area. Despite they are not technically difficult to perform, these approaches can be burdened by postoperative cerebrospinal fluid (CSF) leakage, both at short and long-term follow-up, with an high risk of meningitis. Many techniques were employed to avoid this risk, but it can still be estimated between 2% and 11% according to literature1-4. Spena et al. reported a CSF leakage rate of 6.8% in a previous experience5. As a consequence, newer efforts are necessaries to avoid this potentially lethal complication. By this explorative study, we want to retrospectively analyzed our experience with a newer technique of bone closure, called O'Ring, in patients subdued to posterior fossa surgery by RS, KR and CH approaches, focusing on postoperative CSF leakage (primary objective), wound complications and subcutaneous CSF collections (secondary objectives).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •age ≥18 years,
- •availability of pre- and postoperative radiological and clinical data,
- •a follow-up period of at least 3 months.
排除标准
- •Lacking of clinical, radiological and surgical data
结局指标
主要结局
to estimate incidence of postoperative CSF leakage
时间窗: 7 days
cumulative incidence of postoperative CSF leakage
次要结局
- to estimate incidence CSF leakage at 1- and 3-months of follow-up.(1 and 3 months)
- to estimate the incidence of wound complications postoperatively and at 1- and 3-months(1 and 3 months)
- to estimate the incidence of subcutaneous CSF collections postoperatively and at 1 and 3-months radiological follow-up(1 and 3 months)
研究者
Francesco Guerrini
Doctor
Fondazione IRCCS Policlinico San Matteo di Pavia
