Role of Leukocyte- and Platelet-Rich Fibrin Membranes in Endoscopic Endonasal Skull Base Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 6
- 主要终点
- Cost-effectiveness evaluation based on the effectiveness and the costs of L-PRF versus the current golden standard (Tachosil and Tisseel).
研究概览
简要总结
Prospective investigation of the effectivity of L-PRF membranes for skull base reconstruction after endoscopic endonasal skull base surgery (transsphenoidal) versus classical closure techniques.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants stay masked during the trial, care provider and investigators are unblinded at the surgical procedure and from thereon
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with lesions of the sellar/parasellar region
- •Age > 18 and < 70 years
- •Written informed consent
- •Willingness to adhere to visit schedules
排除标准
- •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)
研究组 & 干预措施
L-PRF
In this arm, dural closure will be performed with the autologous L-PRF
干预措施: Dural closure (Procedure)
Classical Treatment
In this arm, dural closure will be performed with the classical fibrine sealants.
干预措施: Dural closure (Procedure)
结局指标
主要结局
Cost-effectiveness evaluation based on the effectiveness and the costs of L-PRF versus the current golden standard (Tachosil and Tisseel).
时间窗: 4 years
Cost-effectiveness evaluation: compare the costs and the effectiveness of L-PRF versus commercial fibrin sealants.
To compare the prevalence of CSF-leaks after L-PRF closure and after the classical closure techniques for sellar defects to demonstrate non-inferiority
时间窗: 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.
次要结局
- To identify potential risk for closure-failures based on the size of the lesion(4 years)
- To evaluate if the pathology is a potential risk factor for closure-failures(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(4 years)
- To evaluate if the age of the patient is a potential risk factor for closure-failures(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(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(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(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(4 years)
研究者
Laura Van Gerven
Clinical professor, Doctor
Universitaire Ziekenhuizen KU Leuven