Cerebrospinal Fluid LeakNCT04124523
Perioperative CSF Leak Management - an Opinion Study
An observational study of Cerebrospinal Fluid Leak, run by University Hospital, Montpellier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Cerebrospinal Fluid Leak
- How many people
- 153 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 1 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ENT surgeon or neurosurgeon skull base surgery practice
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: International Opinion Study on Peri-operative Cerebrospinal Fluid Leaks Management After Endoscopic Skull Base Surgery
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
- Medical subject headings
- Cerebrospinal Fluid Leak
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of perioperative management of CSF leaks
Evaluation of perioperative management of CSF leaks at pre-treatment (preoperative) with 60 items questionnaire (QCM)
Measured: 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)
Measured: 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)
Measured: maximum 2 weeks (during hospitalization)
Secondary outcomes (3)
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)
Measured: 1 day (pre-treatment)
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)
Measured: 1 day (the end of the surgery)
Comparison of practices of surgeons according by specialties
Comparison of practices of surgeons according by specialties during hospitalization with 60 items questionnaire (QCM)
Measured: maximum 2 weeks (during hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start1 Jan 2019
- Primary completion1 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrospinal Fluid LeakStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valentin Favier, MD, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124523
- Sponsor's protocol ID
- RECHMPL19_0468
- Status last verified
- Sep 2019
- First submitted
- 3 Oct 2019
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Opinion Study on Peri-operative Cerebrospinal Fluid Leaks Management After Endoscopic Skull Base Surgery
- ClinicalTrials.gov ID
- NCT04124523
- Acronym / sponsor ID
- RECHMPL19_0468
- Conditions
- Cerebrospinal Fluid Leak
- Keywords
- skull base surger, CSF leaks, intracranial pressure, endoscopic skull base surgery, CSF depletion, ENT surgeon or neurosurgeon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ENT surgeon or neurosurgeon skull base surgery practice
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
3 secondary outcomes
Comparison of practices of surgeons according by specialties
Time frame: 1 day (pre-treatment)
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
Time frame: maximum 2 weeks (during hospitalization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentin Favier, MD principal investigator
University Hospitals of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrospinal Fluid Leak, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of perioperative management of CSF leaks (time frame: 1 day (pre-treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020; AzTrials last refreshed its copy on 31 Oct 2026.