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 Details — Status: Completed

Administrative data

• NCT number: NCT04124523
• Other study ID #: RECHMPL19_0468
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: September 2019
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: October 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrospinal Fluid Leak

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of perioperative management of CSF leaks	Evaluation of perioperative management of CSF leaks at pre-treatment (preoperative) with 60 items questionnaire (QCM)	1 day (pre-treatment)
Primary	Evaluation of perioperative management of CSF leaks	Evaluation of perioperative management of CSF leaks at the end of the surgery with 60 items questionnaire (QCM)	1 day (the end of the surgery)
Primary	Evaluation of perioperative management of CSF leaks	Evaluation of perioperative management of CSF leaks during hospitalization with 60 items questionnaire (QCM)	maximum 2 weeks (during hospitalization)
Secondary	Comparison of practices of surgeons according by specialties	Comparison of practices of surgeons according by specialties at pre-treatment (preoperative) with 60 items questionnaire (QCM)	1 day (pre-treatment)
Secondary	Comparison of practices of surgeons according by specialties	Comparison of practices of surgeons according by specialties at the end of the surgery with 60 items questionnaire (QCM)	1 day (the end of the surgery)
Secondary	Comparison of practices of surgeons according by specialties	Comparison of practices of surgeons according by specialties during hospitalization with 60 items questionnaire (QCM)	maximum 2 weeks (during hospitalization)