Prospective investigation of the effectivity of L-PRF membranes for skull base reconstruction after endoscopic endonasal skull base surgery (transsphenoidal) versus classical closure techniques.
The investigators want to demonstrate in a prospective, randomized trial including 220 patients undergoing endoscopic endonasal skull base surgery that the use of L-PRF is non-inferior to classical fibrin sealants. Approximately 220 patients undergoing cranial surgery will be enrolled in this randomized, controlled, single-blinded multicenter study to evaluate the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
220
Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair
AZ Sint-Jan
Bruges, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITINGFundació Clínic Per A La Recerca Biomèdica
Barcelona, Spain
NOT_YET_RECRUITINGTo compare the prevalence of CSF-leaks after L-PRF closure and after the classical closure techniques for sellar defects to demonstrate non-inferiority
The primary aim of this study is identifying the role of L-PRF in the endoscopic endonasal closure of skull base defects. More specific, we want to demonstrate in a prospective, randomized trial that the use of L-PRF is non-inferior to classical closure techniques regarding prevalence of CSF-leaks The number of patients with a CSF-leak will be compared between both treatment groups.
Time frame: 4 years
Cost-effectiveness evaluation based on the effectiveness and the costs of L-PRF versus the current golden standard (Tachosil and Tisseel).
Cost-effectiveness evaluation: compare the costs and the effectiveness of L-PRF versus commercial fibrin sealants.
Time frame: 4 years
To identify potential risk for closure-failures based on the size of the lesion
The potential risk for closure-failure (evaluated by the prevalence of CSF-leaks) based size of lesion ( evaluated by Wilson-Hardy classification) will be measured.
Time frame: 4 years
To evaluate if the pathology is a potential risk factor for closure-failures
The potential risk for closure-failure (evaluated by the prevalence of CSF-leaks) based on the pathology will be evaluated.
Time frame: 4 years
To evaluate if the age of the patient is a potential risk factor for closure-failures
The potential risk for closure-failure (evaluated by the prevalence of CSF-leaks) based on the age of the patients will be measured.
Time frame: 4 years
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on a visual analogue scale
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Rhinological symptoms as well as quality of life before and after surgery will be assesed using a visual analogue scale. The symptoms will be scored on a horizontal line of 10 cm, where 0 cm equals "no symptoms" and 10 cm equals "very severe symptoms".
Time frame: 4 years
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the SNOT-22
Rhinological symptoms as well as quality of life before and after surgery will be assesed using a SNOT-22. The symptoms will be scored between 0 and 5 where 0 equals "no symptoms" and 5 equals "very severe symptoms".
Time frame: 4 years
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the skull base questionnaire
Rhinological symptoms as well as quality of life before and after surgery will be assesed using the skull base questionnaire.
Time frame: 4 years
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the EQ-5D
Rhinological symptoms as well as quality of life before and after surgery will be assesed using the EQ-5D
Time frame: 4 years
Evaluate the potential interference of the L-PRF membranes with post-operative imaging by comparing the tumor residue evaluation 3 months and 1 year after surgery
potential interference of the L-PRF membranes with post-operative imaging (MRI) will be evaluated. 3 months after surgery, when the L-PRF membrane is still visible, the MRI images will be evaluated to see if there is tumor residue present or not. After 1 year the presence of tumor residue will be reevaluated. The outcomes will be compared between both evaluation timepoints to asses if L-PRF has interference with the imaging.
Time frame: 4 years