Clinical Trials Logo
  1. Home
  2. Cerebrospinal Fluid Leak
  3. NCT04124523

Perioperative CSF Leak Management - an Opinion Study

Cerebrospinal Fluid Leak Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04124523
Study type Observational
Source University Hospital, Montpellier
Contact
Status Completed
Phase
Start date January 1, 2019
Completion date October 1, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT04057157 - Post-market Assessment of Biodesign Dural Repair Grafts
Withdrawn NCT02902133 - Acetazolamide to Prevent Post Operative CSF Leak Phase 2
Recruiting NCT02927782 - Mobilisation Algorithm After Incidental Durotomy N/A
Completed NCT03566602 - Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery N/A
Completed NCT02891070 - Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery Phase 3
Recruiting NCT04490629 - The Efficacy and Safety of a Latest Dural Substitute N/A
Withdrawn NCT04351061 - Acetazolamide for the Prevention of Post Operative CSF Leak Phase 2
Recruiting NCT04086550 - Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery N/A
Completed NCT02457546 - The EVICEL® Neurosurgery Phase III Study Phase 3
Completed NCT04145544 - A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair. N/A
Active, not recruiting NCT04923867 - Suturable DuraGen™ PMCF Study
Withdrawn NCT03181464 - Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics Phase 4