The Impact of Postoperative Bed Rest on the Repair of Cerebrospinal Fluid (CSF) Leakage After Transnasal Transsphenoidal Pituitary Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Occurrence of CSF leakage within 3 months postoperatively
研究概览
简要总结
Postoperative cerebrospinal fluid (CSF) leakage is a well-known complication that might occur after transnasal transsphenoidal adenomectomy at an incidence of 0.5-15% according to different literature reports. Persistent CSF leakage may lead to intracranial hypotension or meningitis, therefore aggressive management is mandatory. The treatment is immediate repair during transsphenoidal surgery once intraoperative CSF leakage is identified, with the adjunct of postoperative bed rest and/or lumbar drainage. However, due to the advances in endoscopic endonasal skull base surgery, some surgical teams have advocated that postoperative bed rest may not be necessary if appropriate repair have been performed. High-flow CSF leakage typically occurs in an extended endonasal approach to the anterior or posterior cranial fossa, whereas CSF leakage resulting from transsphenoidal pituitary surgery is usually easier to be repaired.
Bed rest is stressful management for patients and poses increased risks in many ways, such as the need for an indwelling urinary catheter, musculoskeletal pain, affected sleep quality, and increased possibility of thromboembolism. It is crucial that the duration of bed rest be cut short or totally avoided if clinically acceptable. In reviewing the literature, there is insufficient evidence supporting the routine use of postoperative bed rest after CSF leakage repair in transsphenoidal surgery. This study aims to compare the efficacy of successful CSF leakage repair with or without postoperative bed rest with an open-label randomized trial design.
详细描述
Postoperative CSF leakage is a well-known complication that might occur after transnasal transsphenoidal adenomectomy at an incidence of 0.5-15% according to different literature reports. Persistent CSF leakage may lead to intracranial hypotension or meningitis, therefore aggressive management is mandatory. The reason that a postoperative CSF leakage would occur mostly is due to the rupture of arachnoid membrane caused by intraoperative manipulation, resulting in direct communication between the subarachnoid space and the nasal cavity. Even when in cases without intraoperative CSF leakage detected, there is a reported incidence of 1.3% of postoperative CSF leakage.
The rate of intraoperative CSF leakage varies in different tumor sizes, tumor extents, tumor natures, and surgical teams, and it could not be precisely documented as 23.3-60% were reported. The treatment is immediate repair during transsphenoidal surgery once intraoperative CSF leakage is identified, with the adjunct of postoperative bed rest and/or lumbar drainage. However, due to the advances in endoscopic endonasal skull base surgery, some surgical teams have advocated that postoperative bed rest may not be necessary if appropriate repair have been performed. High-flow CSF leakage typically occurs in an extended endonasal approach to the anterior or posterior cranial fossa, whereas CSF leakage resulting from transsphenoidal pituitary surgery is usually easier to be repaired.
Bed rest is stressful management for patients and poses increased risks in many ways, such as the need for an indwelling urinary catheter, musculoskeletal pain, affected sleep quality, and increased possibility of thromboembolism. It is crucial that the duration of bed rest be cut short or totally avoided if clinically acceptable. In reviewing the literature, there is insufficient evidence supporting the routine use of postoperative bed rest after CSF leakage repair in transsphenoidal surgery. This study aims to compare the efficacy of successful CSF leakage repair with or without postoperative bed rest with an open-label randomized trial design.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pituitary adenoma requiring surgical resection.
排除标准
- •Spontaneous CSF leakage occurs prior to transsphenoidal surgery.
- •The growth of adenoma extends to anterior cranial fossa or clival region.
- •The growth of adenoma extends to 3rd ventricle.
- •Prior history of transsphenoidal surgery.
- •Prior history of radiotherapy or radiosurgery to the sella or nearby skull base region.
- •Class 2 obesity or extremely obese: BMI ≧
- •Pregnant or lactating women.
- •Patients who could not give informed consent.
结局指标
主要结局
Occurrence of CSF leakage within 3 months postoperatively
时间窗: 12 weeks after the date of surgery
Any documented CSF leakage within 3 months postoperatively. Confirmation of CSF leakage could either be: 1. typical symptoms of CSF rhinorrhea, plus visible clear and colorless rhinorrhea with positive glucose response 2. atypical symptoms of CSF rhinorrhea, plus visualization of clear and colorless fluid from the operative site via sinoscope 3. atypical symptoms of CSF rhinorrhea, plus identifiable fluid accumulation in the sphenoid sinus and suspicious site of CSF fistula via neuroimaging modalities
次要结局
- Occurrence of meningitis within 3 months postoperatively(12 weeks after the date of surgery)
- Results of 36-Item short form health survey (SF-36) surveys(On postoperative day 1, postoperative day 7, postoperative day 28, postoperative week 12 and postoperative week 24.)
- Length of hospital stay(24 weeks after the date of surgery)