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临床试验/NCT06620952
NCT06620952已完成不适用

Effect of the "O-ring" Technique in Reducing Cerebrospinal Fluid Leak in Posterior Fossa Surgery: an Explorative Study

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年7月16日最近更新:
适应症

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

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

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Guerrini

Doctor

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

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