Cerebrospinal Fluid Leakage Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06419855 -
Study to Evaluate the Effectivity and Safety of BIOSCAFF®H Compared to DuraGen®, in Patients Undergoing Dural Repair
|
||
Completed |
NCT01295619 -
Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective Craniotomy
|
N/A | |
Not yet recruiting |
NCT05898074 -
Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery
|
N/A |