Evaluation of Internal Nasal Splint-Supported Free Graft Versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluation of Internal Nasal Splint-Supported Free Graft versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
研究概览
简要总结
The study aims to compare the feasibility and effectiveness of using an internal nasal splint- supported free graft versus a nasoseptal flap alone for endoscopic repair of bilateral CSF leaks.
Research question:
Does the use of an internal nasal splint to support a free graft during endoscopic repair of bilateral CSF leaks improve outcomes compared to the use of a nasoseptal flap alone?
详细描述
Cerebrospinal fluid (CSF) leaks are classified as traumatic, iatrogenic, or spontaneous/idiopathic. Traumatic causes include blunt or penetrating facial injuries, while iatrogenic causes stem from neurosurgical or otolaryngologic procedures, such as Functional Endoscopic Sinus Surgery (FESS).
Spontaneous CSF leaks, often linked to elevated intracranial pressure (ICP), may occur in conditions like Idiopathic Intracranial Hypertension (IIH) or due to congenital skull base defects and tumors [2]. Risk factors for spontaneous leaks include obesity, female gender, and obstructive sleep apnea, with studies showing 72% of affected patients are female and 45% have sleep apnea.
Benign Intracranial Hypertension (BIH), also known as IIH or Pseudotumor Cerebri (PTC), involves increased brain pressure without structural abnormalities and normal CSF content. Spontaneous CSF rhinorrhea, increasingly prevalent (14-55%), often requires thorough investigations (e.g., fundus examination, CT/MRI, neurological consultation) to exclude intracranial hypertension before endoscopic repair.
Lumbar drain with CSF manometry is reserved for recurrent cases, often due to benign CSF tension increases despite normal preoperative findings. Successful repair requires competent flaps/grafts to withstand CSF pressure during healing. Recurrence necessitates further investigations and may require additional CSF diversion or shunting.
Key steps for successful repair include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •1- Adults (≥18 years). 2- Patients with bilateral CSF leaks confirmed by imaging and biochemical testing (e.g., beta-2 transferrin).
- •3- Patients with bilateral CSF leak and sever septal spur. 4- Patients with bilateral CSF leak and history of submucosal resection of nasal septum.
- •5- Patients with bilateral CSF leak and large septal perforation. 6- Patients with bilateral CSF Leak and septal granuloma.
排除标准
- •1- Patients with contraindications to endoscopic surgery. 2- Active sinus or nasal infections. 3- Previous nasal or skull base surgery affecting the repair site.
研究组 & 干预措施
Evaluation of Internal Nasal Splint-Supported Free Graft in Endoscopic Skul
• Group B: Nasoseptal flap alone.
- Standard nasoseptal flap technique used for skull base repair.
干预措施: Internal Nasal Splint-Supported Free Graft (Device)
Nasoseptal Flap for Endoscopic Skull
• Group A: Free graft + Internal nasal splint
- Free graft material (e.g., fascia lata, fat, synthetic dural substitute) placed over the defect.
- Internal nasal splint applied to support the graft and maintain its position
干预措施: Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks (Device)
结局指标
主要结局
Evaluation of Internal Nasal Splint-Supported Free Graft versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
时间窗: baseline
• Primary Objective: \- To evaluate the effectiveness of internal nasal splints in improving the feasibility and success rate of free grafts during endoscopic repair of bilateral CSF leaks.
次要结局
未报告次要终点
研究者
Amr Mahr Shady
resident
Kafrelsheikh University