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.
- Conditions
- Leakage of brain fluids.10040795
- Registration Number
- NL-OMON32695
- Lead Sponsor
- ycomed
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 28
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.
* 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the occurrence of either a clinically evident CSF-leak<br /><br>or a clinically evident pseudomeningocele.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoint is defined as the incidence of non-clinically evident<br /><br>epidural fluid collections found on CT- or MRI-scans and will be evaluated<br /><br>post-operatively until the Follow-up visit.</p><br>