Perioperative CSF Leak Management - an Opinion Study

NCT04124523 | Completed

• 1 other identifier: RECHMPL19_0468
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrospinal Fluid Leak

Keywords

skull base surger; CSF leaks; intracranial pressure; endoscopic skull base surgery; CSF depletion; ENT surgeon or neurosurgeon

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (3)

• Comparison of practices of surgeons according by specialties

  1 day (pre-treatment)

• Comparison of practices of surgeons according by specialties

  1 day (the end of the surgery)

• Comparison of practices of surgeons according by specialties

  maximum 2 weeks (during hospitalization)

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ENT surgeon or neurosurgeon skull base surgery practice

You may qualify if:

• 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
• Subject unable to read or/and write
• Undergraduate students
• Refusal to participate

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Cerebrospinal Fluid Leak

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Valentin Favier, MD

  University Hospitals of Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 11, 2019
• Study Start: January 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2019
• Last Updated: June 5, 2020

Record last verified: 2019-09

Locations

FR (1)