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NCT Number: NCT04124523

Perioperative CSF Leak Management - an Opinion Study

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.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uh Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 11, 2019
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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