Cerebrospinal Fluid Rhinorrhea After Functional Endoscopic Sinus Surgery

Brief Title

Cerebrospinal Fluid Rhinorrhea After Functional Endoscopic Sinus Surgery

Official Title

Auftreten Von Okkultem Asymptomatischem Liqourverlust Nach Nebenhöhlenoperationen Eine Prospektive Kohortenstudie

Brief 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. 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 Type

Observational


Primary Outcome

Beta-2-Transferrin positive or negative


Condition

Cerebrospinal Fluid Leakage



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

31

Start Date

February 2015

Completion Date

December 31, 2016

Primary Completion Date

December 31, 2016

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  Olanned or accidental opening of the skull base

          -  Tumor in the skull base

          -  Pre-existing known rhinoliquorrhoe

          -  Lack of understanding the study or investigation
      

Gender

All

Ages

18 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT02382692

Organization ID

SM_27_02_2015


Responsible Party

Sponsor

Study Sponsor

University of Zurich


Study Sponsor

, , 


Verification Date

May 2017