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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Classical Treatment | Placebo Comparator | In this arm, dural closure will be performed with the classical fibrine sealants. |
|
| L-PRF | Active Comparator | In this arm, dural closure will be performed with the autologous L-PRF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dural closure | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To 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. | 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. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 years |
| To evaluate if the pathology is a potential risk factor for closure-failures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Van Gerven, prof | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint-Jan | Bruges | 8000 | Belgium | |||
| UZ Leuven |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37525278 | Derived | Coucke B, Van Hoylandt A, Jorissen M, Meulemans J, Decramer T, van Loon J, Vander Poorten V, Theys T, Van Gerven L. Leukocyte- and platelet-rich fibrin in endoscopic endonasal skull base reconstruction: study protocol for a multicenter prospective, parallel-group, single-blinded randomized controlled non-inferiority trial. Trials. 2023 Jul 31;24(1):488. doi: 10.1186/s13063-023-07492-w. |
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Randomized controlled clinical trial
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Participants stay masked during the trial, care provider and investigators are unblinded at the surgical procedure and from thereon
The potential risk for closure-failure (evaluated by the prevalence of CSF-leaks) based on the pathology will be evaluated. |
| 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. | 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 | 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". | 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 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". | 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 assessed using the skull base questionnaire. | 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 assessed using the EQ-5D | 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. | 4 years |
| Leuven |
| 3000 |
| Belgium |
| Fundació Clínic Per A La Recerca Biomèdica | Barcelona | 08036 | Spain |