NL-OMON32695尚未招募3 期
TachoSil® versus current practice in dura sealing techniques for the prevention of postoperative cerebrospinal fluid (CSF) leaks in patients undergoing skull base surgery: An open label, randomised, controlled, multicentre, parallel group efficacy and safety trial. - TASA
ycomed0 个研究点目标入组 28 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Is the surgical approach/procedure consistent with skull base surgery? I.e. at least one of the following:
- •a. Lateral approach to the foramen magnum: far lateral, extreme lateral, anterolateral, posterolateral,
- •b. Approach to the jugular foramen: infratemporal, juxta condylar, transjugular,
- •c. Approach to the cerebello pontine (CP) angle and petrous apex retrosigmoïd, translabyrinthine, retrolabyrinthine, transcochlear (limited transpetrosal),
- •d. Approach to the middle fossa: subtemporal (+/- petrous apex drilling), pteronial approach (any fronto temporal approach +/- orbitozygomatic deposition),
- •e. Approach to the anterior fossa: subfrontal (uni or bilateral),
- •f. Approach to the midline posterior fossa.
排除标准
- •* Has the patient been subject to emergency surgery within the last 3 months i.e. all non-elective surgery?
- •* Is the patient expected to need additional neurosurgery within the follow-up periodof Week 7±1 at the same surgical site?
- •* Is the surgical approach/procedure consistent with any transcranial or transfacial or combination of transcranial - transfacial approaches with wide defect in the skull base? I.e. any of the following:
- •g. Trans basal approach,
- •h. Total petrosectomy,
- •i. Trans facial approach,
- •j. Trans sphenoïdal approach,
- •k. Endoscopic procedures,
- •l. Trans oral approach (and any extension: Le Fort, mandibulotomy).
研究者
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