Semi-sitting Versus Supine Position in Endoscopic Skull Base Surgery (PosESS-Study) - Study Protocol for a Randomized-controlled Single-blinded Superiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Intraoperative blood loss
研究概览
简要总结
This study is to prospectively compare the standard supine (control group) and the semi-sitting position (head elevation of 30°; intervention group) in endoscopic endonasal pituitary surgery.
详细描述
The endonasal endoscopic approach (EEA) for pituitary surgery is standardly performed with the patient in supine position (SP). The semi-sitting position (SSP) is routinely used for the traditional microscopic transsphenoidal approach and also for posterior fossa surgery. The SSP results in lower intracranial pressure when compared to the supine position due to decreased venous congestion. As a result, intraoperative bleeding may be reduced, potentially leading to decreased surgical morbidity and improved surgical workflow. Studies during endoscopic sinus surgery have shown a significant reduction of blood loss when the patient is placed in a reverse Trendelenburg position with a head elevation of 30°. This study is to prospectively compare the standard supine (control group) and the semi-sitting position (head elevation of 30°; intervention group) in endoscopic endonasal pituitary surgery.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a presumed pituitary pathologies who are suitable for endoscopic endonasal surgical resection
排除标准
- •Patients with known hemorrhagic or thrombophilic disorders
- •Patients with conditions associated with high central venous pressure: congestive heart failure, pulmonary hypertension, chronic obstructive pulmonary disease (COPD), interstitial lung disease, pregnancy
- •Patients with poor cardiopulmonary condition (unable to perform 4 metabolic equivalents without stopping (climb a flight of stairs))
结局指标
主要结局
Intraoperative blood loss
时间窗: Intraoperative
Intraoperative blood loss, calculated as follow: volume in the suction bag minus volume of rinsing water in Milliliters (ml). The surgery is divided into four steps: 1. endonasal phase, 2. osteodural exposure. 3. sellar stage and 4. skull base defect closure. For each step, the primary outcome will be assessed.
Frequency of interruption of the surgical workflow due to disturbing blood or a bleeding in the surgical field (number)
时间窗: During surgery
Frequency of interruption of the surgical workflow due to disturbing blood or a bleeding in the surgical field. This will be assessed by an independent blinded neurosurgeon, who will watch the operative video after the surgery.
次要结局
- Degree of descent or prolapse of the diaphragma sellae into the sellar cavity(Intraoperative)
- Operative time (minutes)(During surgery)
- Change in intraoperative Mean Arterial Pressure (MAP)(Intraoperative)
- Amount of intravenous fluid administered during surgery (ml)(Intraoperative)
- Need for vasoactive drugs (vasopressors) (number)(at Day 1 (day of surgery))
- Incidence of air embolism (number)(at Day 1 (day of surgery))
- Occurrence of a cerebrospinal fluid (CSF) leak during surgery (assessed by the operating neurosurgeon) (yes/ no)(During surgery)
- Surgical ergonomics(at Day 1 (day of surgery))
- Incidence of rhinoliquorrhoea (number)(at 3 months after surgery)