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Perioperative CSF Leak Management - an Opinion Study

International Opinion Study on Peri-operative Cerebrospinal Fluid Leaks Management After Endoscopic Skull Base Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04124523
Enrollment
153
Registered
2019-10-11
Start date
2019-01-01
Completion date
2019-10-01
Last updated
2020-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrospinal Fluid Leak

Keywords

skull base surger, CSF leaks, intracranial pressure, endoscopic skull base surgery, CSF depletion, ENT surgeon or neurosurgeon

Brief summary

Cerebrospinal fluid (CSF) leak is a rare condition. When it involves the ventral skull base, a surgical closure may be achieved using endoscopic skull base surgery techniques. The major principles remain in achieving a watertight closure that can also support the brain (and avoid brain sagging) in case of extensive skull base defects. Surgical techniques are well described. Many clinical factors may influence the successful rate of the reconstruction. However, there is a lack of clinical study on perioperative management of CSF leaks. The purpose of this study is to gather the opinion of skull base surgeons on the post-operative management of patients to avoid CSF leak recurrence. •Methods: The investigators will collect data from skull base surgeons using an electronic survey questionnaire (Google Form, Google, Mountain View, California, U.S.A.) submitted by e-mail to the members of the French Association of Rhinology, to the European Rhinologic Society, to the French college of neurosurgeons, to the Italian skull base society members, and to the former students of the European endoscopic skull base diploma. This is an anonymous 60-items survey. Questions were classified in eight sections: general questions, material used at the end of the surgical procedure, post-operative resting position, drugs, CSF depletion, post-operative advices, explorations in case of early recurrence of the rhinorrhoea, and follow-up modalities. •Discussion: The investigators aim to understand the actual practice of skull base surgeons after closure of ventral skull base CSF leaks. This can serve as a basis for conducting clinical studies in the future.

Interventions

None listed

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No

Inclusion criteria

An individual must fulfill all of the following criteria in order to be eligible for study enrollment: * Active skull base surgery practice (ENT surgeon or neurosurgeon) * Volunteering Non inclusion criteria * Subject unable to read or/and write * Undergraduate students * Refusal to participate

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of perioperative management of CSF leaks1 day (pre-treatment)Evaluation of perioperative management of CSF leaks at pre-treatment (preoperative) with 60 items questionnaire (QCM)

Secondary

MeasureTime frameDescription
Comparison of practices of surgeons according by specialties1 day (pre-treatment)Comparison of practices of surgeons according by specialties at pre-treatment (preoperative) with 60 items questionnaire (QCM)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026