NCT04124523

Perioperative CSF Leak Management - an Opinion Study

Completed Last updated 5 June 2020

What this trial tests

trial in Cerebrospinal Fluid Leak in 153 participants. Completed in 1 October 2019.

Timeline

1 January 2019

Primary endpoint
1 September 2019

1 October 2019

Quick facts

Lead sponsor	University Hospital, Montpellier
Status	Completed
Study type	OBSERVATIONAL
Enrollment	153
Start date	1 January 2019
Primary completion	1 September 2019
Estimated completion	1 October 2019
Sites	1 location across France

Conditions studied

• Cerebrospinal Fluid Leak — all drugs for Cerebrospinal Fluid Leak →

Sponsor

University Hospital, Montpellier

Who can join

25 and older, any sex, with Cerebrospinal Fluid Leak. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.