Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Perioperative CSF Leak Management - an Opinion Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date October 3, 2019
First Posted Date October 11, 2019
Last Update Posted Date October 11, 2019
Actual Study Start Date January 1, 2019
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 10, 2019)
  • 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)
  • 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)
  • 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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 10, 2019)
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Perioperative CSF Leak Management - an Opinion Study
Official Title International Opinion Study on Peri-operative Cerebrospinal Fluid Leaks Management After Endoscopic Skull Base Surgery
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population ENT surgeon or neurosurgeon skull base surgery practice
Condition Cerebrospinal Fluid Leak
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 10, 2019)
153
Original Actual Enrollment Same as current
Actual Study Completion Date October 1, 2019
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04124523
Other Study ID Numbers RECHMPL19_0468
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: NC
Responsible Party University Hospital, Montpellier
Study Sponsor University Hospital, Montpellier
Collaborators Not Provided
Investigators
Principal Investigator: Valentin Favier, MD University Hospitals of Montpellier
PRS Account University Hospital, Montpellier
Verification Date September 2019