Cranial Sutures; Closure
Conditions
Keywords
L-PRF, fibrin sealants, endoscopic endonasal skull base reconstruction
Brief summary
Prospective investigation of the effectivity of L-PRF membranes for skull base reconstruction after endoscopic endonasal skull base surgery (transsphenoidal) versus classical closure techniques.
Detailed description
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.
Interventions
PROCEDUREDural closure
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
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants stay masked during the trial, care provider and investigators are unblinded at the surgical procedure and from thereon
Intervention model description
Randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with lesions of the sellar/parasellar region * Age \> 18 and \< 70 years * Written informed consent * Willingness to adhere to visit schedules
Exclusion criteria
* Age \< 18 and \> 70 years * Any underlying rhinological condition like nasal polyps, which may interfere with the obtained results * Any disorder which might compromise the ability of a patient to give truly informed consent for participation in this study * Enrollment in other investigational drug trial(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare the prevalence of CSF-leaks after L-PRF closure and after the classical closure techniques for sellar defects to demonstrate non-inferiority | 4 years | 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. |
| Cost-effectiveness evaluation based on the effectiveness and the costs of L-PRF versus the current golden standard (Tachosil and Tisseel). | 4 years | Cost-effectiveness evaluation: compare the costs and the effectiveness of L-PRF versus commercial fibrin sealants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the skull base questionnaire | 4 years | Rhinological symptoms as well as quality of life before and after surgery will be assessed using the skull base questionnaire. |
| Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the EQ-5D | 4 years | Rhinological symptoms as well as quality of life before and after surgery will be assessed using the EQ-5D |
| To identify potential risk for closure-failures based on the size of the lesion | 4 years | 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. |
| To evaluate if the pathology is a potential risk factor for closure-failures | 4 years | The potential risk for closure-failure (evaluated by the prevalence of CSF-leaks) based on the pathology will be evaluated. |
| To evaluate if the age of the patient is a potential risk factor for closure-failures | 4 years | The potential risk for closure-failure (evaluated by the prevalence of CSF-leaks) based on the age of the patients will be measured. |
| 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 | 4 years | 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. |
| Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on a visual analogue scale | 4 years | Rhinological symptoms as well as quality of life before and after surgery will be assessed 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". |
| Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the SNOT-22 | 4 years | Rhinological symptoms as well as quality of life before and after surgery will be assessed using a SNOT-22. The symptoms will be scored between 0 and 5 where 0 equals "no symptoms" and 5 equals "very severe symptoms". |
Countries
Belgium, Spain
Contacts
PRINCIPAL_INVESTIGATORLaura Van Gerven, prof
UZ Leuven
Outcome results
None listed