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Perioperative CSF Leak Management - an Opinion Study

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ClinicalTrials.gov Identifier: NCT04124523
Recruitment Status : Completed
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease
Cerebrospinal Fluid Leak

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Study Type : Observational
Actual Enrollment : 153 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: International Opinion Study on Peri-operative Cerebrospinal Fluid Leaks Management After Endoscopic Skull Base Surgery
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Evaluation of perioperative management of CSF leaks [ Time Frame: 1 day (pre-treatment) ]
    Evaluation of perioperative management of CSF leaks at pre-treatment (preoperative) with 60 items questionnaire (QCM)

  2. Evaluation of perioperative management of CSF leaks [ Time Frame: 1 day (the end of the surgery) ]
    Evaluation of perioperative management of CSF leaks at the end of the surgery with 60 items questionnaire (QCM)

  3. Evaluation of perioperative management of CSF leaks [ Time Frame: maximum 2 weeks (during hospitalization) ]
    Evaluation of perioperative management of CSF leaks during hospitalization with 60 items questionnaire (QCM)


Secondary Outcome Measures :
  1. Comparison of practices of surgeons according by specialties [ Time Frame: 1 day (pre-treatment) ]
    Comparison of practices of surgeons according by specialties at pre-treatment (preoperative) with 60 items questionnaire (QCM)

  2. Comparison of practices of surgeons according by specialties [ Time Frame: 1 day (the end of the surgery) ]
    Comparison of practices of surgeons according by specialties at the end of the surgery with 60 items questionnaire (QCM)

  3. Comparison of practices of surgeons according by specialties [ Time Frame: maximum 2 weeks (during hospitalization) ]
    Comparison of practices of surgeons according by specialties during hospitalization with 60 items questionnaire (QCM)



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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ENT surgeon or neurosurgeon skull base surgery practice
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124523


Locations
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France
Uh Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Valentin Favier, MD University Hospitals of Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04124523     History of Changes
Other Study ID Numbers: RECHMPL19_0468
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
skull base surger
CSF leaks
intracranial pressure
endoscopic skull base surgery
CSF depletion
ENT surgeon or neurosurgeon
Additional relevant MeSH terms:
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Cerebrospinal Fluid Leak
Neurologic Manifestations
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Signs and Symptoms
Wounds and Injuries