Cerebrospinal Fluid LeakageNCT02382692
Cerebrospinal Fluid Rhinorrhea After Functional Endoscopic Sinus Surgery
An observational study of Cerebrospinal Fluid Leakage, run by University of Zurich at 1 site in Switzerland.
Trial summary
Sinus surgery is a common procedure. A potential complication is injuring the membranes of the brain. This can lead to leakage of brain fluid through the nose. We would like to estimate the incident rates of that complication. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cerebrospinal Fluid Leakage
- How many people
- 31 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2015to 31 Dec 2016
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with indication to a sinus intervention without planned opening of the skull base
Who may be able to join
- All patients with planned sinus surgery in terms of Ethmoidektomie / Sphenoethmoidektomie or Frontosphenoethmoidektomie
- Male and female patients aged 18 to 99 years
- Written consent of the participating person after the enlightenment
Who cannot join
- Olanned or accidental opening of the skull base
- Tumor in the skull base
- Pre-existing known rhinoliquorrhoe
- Lack of understanding the study or investigation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Auftreten Von Okkultem Asymptomatischem Liqourverlust Nach Nebenhöhlenoperationen Eine Prospektive Kohortenstudie
Sinus surgery is a common procedure. A potential complication is injuring the membranes of the brain. This can lead to leakage of brain fluid through the nose. We would like to estimate the incident rates of that complication. At the end of the operation, a thin gauze is inserted into the nose on both sides in addition to the usual tampon. This gauze will be analyzed at the laboratory for beta-2-transferrin, which is a biomarker for brain liquid.
Read the detailed description
Sinus surgery is a common procedure in rhinology for the treatment of chronic inflammation, tumors and other pathologies. These procedures are performed in the immediate vicinity of the skull base. The risk of injuring the membranes covering the brain in a way that requires further treatment is less than 1% [ 1]. Such Injuries to the skull base could lead to the loss of cerebrospinal fluid (CSF). The destruction of the natural barrier raises the potential risk of ascending infections of the membranes and the brain itself from the nose. Leakage of cerebrospinal fluid in the usually bloody surgical field of view is not always distinguishable and is sometimes only noticed postoperatively. The spontaneous closure of a leaky membrane of the brain without further surgical treatment is known. This is why small traumata in the skull base often remain undetected.
At the end of the operation, a thin gauze is inserted into the nose on both sides in addition to the usual tampon. The tampon and the additional gauze are removed the day after the operation and will be sent with a tube of venous blood to the laboratory. The gauze and the venous blood will be checked for beta-2-transferrin, which is a biomarker for cerebrospinal fluid.
During further clinical standard controls will the patient be asked about symptoms of fluid leak through the nose.
If positive, regardless to this study, the patient must have an additional CT scan of the sinuses and another blood sample checking for beta-2-transferrin.
- Conditions
- Cerebrospinal Fluid Leakage
- Medical subject headings
- Cerebrospinal Fluid Leak
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-2-Transferrin positive or negative
Measured: 1 day postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrospinal Fluid LeakageStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382692
- Sponsor's protocol ID
- SM_27_02_2015
- Status last verified
- May 2017
- First submitted
- 2 Mar 2015
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Soyka MB, Holzmann D. Correlation of complications during endoscopic sinus surgery with surgeon skill level and extent of surgery. Am J Rhinol. 2005 May-Jun;19(3):274-81.
PubMed 16011134
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auftreten Von Okkultem Asymptomatischem Liqourverlust Nach Nebenhöhlenoperationen Eine Prospektive Kohortenstudie
- ClinicalTrials.gov ID
- NCT02382692
- Acronym / sponsor ID
- SM_27_02_2015
- Conditions
- Cerebrospinal Fluid Leakage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 9 Mar 2015 (estimated)
- 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.
Sinus surgery is a common procedure. A potential complication is injuring the membranes of the brain. This can lead to leakage of brain fluid through the nose. We would like to estimate the incident rates of that complication. At the end of the operation, a thin gauze is inserted into the nose on both sides in addition to the usual tampon. This gauze will be analyzed at the laboratory for beta-2-transferrin, which is a biomarker for brain liquid.
Detailed description
Sinus surgery is a common procedure in rhinology for the treatment of chronic inflammation, tumors and other pathologies. These procedures are performed in the immediate vicinity of the skull base. The risk of injuring the membranes covering the brain in a way that requires further treatment is less than 1% [ 1]. Such Injuries to the skull base could lead to the loss of cerebrospinal fluid (CSF). The destruction of the natural barrier raises the potential risk of ascending infections of the membranes and the brain itself from the nose. Leakage of cerebrospinal fluid in the usually bloody surgical field of view is not always distinguishable and is sometimes only noticed postoperatively. The spontaneous closure of a leaky membrane of the brain without further surgical treatment is known. This is why small traumata in the skull base often remain undetected.
At the end of the operation, a thin gauze is inserted into the nose on both sides in addition to the usual tampon. The tampon and the additional gauze are removed the day after the operation and will be sent with a tube of venous blood to the laboratory. The gauze and the venous blood will be checked for beta-2-transferrin, which is a biomarker for cerebrospinal fluid.
During further clinical standard controls will the patient be asked about symptoms of fluid leak through the nose.
If positive, regardless to this study, the patient must have an additional CT scan of the sinuses and another blood sample checking for beta-2-transferrin.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indication to a sinus intervention without planned opening of the skull base
Key inclusion criteria (3 listed)
- All patients with planned sinus surgery in terms of Ethmoidektomie / Sphenoethmoidektomie or Frontosphenoethmoidektomie
- Male and female patients aged 18 to 99 years
- Written consent of the participating person after the enlightenment
Key exclusion criteria (4 listed)
- Olanned or accidental opening of the skull base
- Tumor in the skull base
- Pre-existing known rhinoliquorrhoe
- Lack of understanding the study or investigation
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
Beta-2-Transferrin positive or negative
Time frame: 1 day postoperative
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 4 May 2017.
- Background: PubMed 16011134Soyka MB, Holzmann D. Correlation of complications during endoscopic sinus surgery with surgeon skill level and extent of surgery. Am J Rhinol. 2005 May-Jun;19(3):274-81.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Leakage, run by University of Zurich at 1 site in Switzerland.
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 3 inclusion and 4 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 4 May 2017. 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 Switzerland. 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?
Beta-2-Transferrin positive or negative (time frame: 1 day postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02382692, which also lists 1 linked publication.
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 4 May 2017; AzTrials last refreshed its copy on 1 Nov 2026.