Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence: a Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 254
- 试验地点
- 3
- 主要终点
- Recurrence
研究概览
简要总结
Objective: Determine the effect of the postoperative trendelenburg position on the recurrence of chronic subdural hematoma (CSH) in patients undergoing surgery.
Materials and Methods: An open-label, randomized, controlled clinical trial was conducted in three hospitals in Medellín. Patients with CSH were enrolled and assigned to the trendelenburg position (30° leg elevation and 10° head tilt) or a flat bed for 24 hours postoperatively. CSH recurrence was measured at 3 months, along with functional outcome (modified Rankin scale), adverse events, and comfort (Likert scale).
详细描述
Objective
Determine the effect of the postoperative trendelenburg position on the recurrence of chronic subdural hematoma (CSH) in patients undergoing surgery.
Materials and Methods
An open-label, randomized, controlled clinical trial was conducted in three hospitals in Medellín. Patients with CSH were enrolled and assigned to the trendelenburg position (30° leg elevation and 10° head tilt) or a flat bed for 24 hours postoperatively. CSH recurrence was measured at 3 months, along with functional outcome (modified Rankin scale), adverse events, and comfort (Likert scale).
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The nature of this intervention did not allow for masking of treatment allocation, so both patients and their care team knew their assigned arm, while outcome assessors and data analysts remained blinded to the allocation.
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
- •The study included patients aged 18 years or older who required surgical management of symptomatic CSH confirmed by CT scan and whose informed consent was given by the patient or responsible family member to participate in the study
排除标准
- •Pregnant or breastfeeding
- •Conditions in which the trendelenburg position might not be safe, such as intracranial hypertension without a drain to allow evacuation of the hematoma, cardiovascular instability (severe heart failure, unstable angina, cardiogenic pulmonary edema), acute respiratory distress syndrome without a secure airway, glaucoma, spinal cord trauma not stabilized with surgery, peripheral vascular disease,
- •History of ipsilateral chronic subdural hematoma drainage, intracranial hypotension syndrome, ventriculoperitoneal shunting
- •Simultaneous participation in any other clinical trial.
研究组 & 干预措施
Control
Control group received the usual postoperative care for patients with CSH, which consisted of strict neurological monitoring for at least 24 hours in an inpatient ward or a more complex setting depending on the patient's clinical condition. The head of the patient was positioned neutral (0°), as were the lower limbs, according to institutional care guidelines. The drain (a latex-gloved reservoir or Hemovac drain) was positioned inferior to the head to promote drainage of any subdural debris. Negative pressure was not used except in patients with Hemovac and a subgaleal drain. Typically, after 24 hours of clinical monitoring and symptom improvement, the drain was removed, and the patient was sent home with recommendations and warning signs, if the patient's clinical condition permitted. Postoperative follow-up imaging was not routinely performed as there was no evidence of clinical benefit.
Trendelenburg
In addition to the management described above, the postoperative position was modified in the intervention group (trendelenburg). After admission to the hospital unit (general ward, special care, or intensive care unit), the patient's position was adjusted with a 30° leg elevation and a 10° downward head tilt. Proper positioning was verified with a goniometer. This position was maintained until the drains were removed, and the patient was then positioned according to usual care. If the patient decided to get out of bed, the nurse occluded the drains and reopened them when the patient returned to the position described for each group.
干预措施: Trendelenburg position (Other)
结局指标
主要结局
Recurrence
时间窗: 3 months
Proportion of patients who experienced recurrence of chronic subdural hematoma at 3 months of follow-up and required repeat surgery
次要结局
- proportion of patients with favorable functional outcome at 3 months, as measured by the modified Rankin Scale.(3 months)
研究者
Ignacio Alberto Gonzalez Borrero
Neurosurgeon
Universidad de Antioquia