Compact Trial - A Randomized Controlled Trial Investigating Optimal Treatment for Chronic Subdural Hematoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Reoperation rate
研究概览
简要总结
Setup of comparative trial The goal of this study is to determine whether one surgical treatment for chronic subdural hematoma is better than the other. Patients with a clear indication for drainage of subdural hematoma (as stated under "Surgical options") will be randomized into three groups. One group will receive twist drill craniostomy followed by drainage during 48 hours. One group will undergo burr hole drainage (single if possible, double if necessary) with irrigation and drainage during 48 hours postoperatively. One group will undergo a minicraniotomy with trephine or craniotome, with wide opening of all visible membranes, rigorous irrigation and placement of Jackson-Pratt drain, followed by closed system draining during 48 hours. Postoperative results and complications will be compared between the three groups.
详细描述
Study design The study is set up as an open randomized controlled three-arm trial. Patients will be randomized into three groups.
Study setup and procedures The goal of this study is to determine if one surgical treatment for chronic subdural hematoma is better than the other. Patients with a clear indication for drainage of subdural hematoma (as stated under "Surgical options") will be randomized into three groups. One group will receive twist drill craniostomy followed by drainage during 48 to 96 hours. One group will undergo burr hole drainage (single if possible, double if necessary) with irrigation and drainage during 48 to 96 hours postoperatively. One group will undergo a minicraniotomy with trephine or craniotome, with wide opening of all visible membranes, rigorous irrigation and placement of Jackson-Pratt drain, followed by drainage during 48 to 96 hours.
Patients diagnosed with chronic subdural hematoma on CT scan, will be operated on as soon as possible. The type of operation will be determined by randomization. The duration of surgery as well as presence of brain reexpansion (in case of burr hole or minicraniotomy) will be recorded. Postoperatively, patients will be transferred to the neurosurgery ward with a subdural drainage system in place. Drainage system is removed 48 to 96 hours postoperatively, regardless of the type of operation (48 hours standard; longer period of drainage if drainage less than 50cc/24h evaluated on the second 24 hours postoperatively. Maximal time of continuous drainage is 4 days or 96 hours postoperatively). Drained volume will be recorded. Evaluation will be performed preoperatively, 48h postoperatively, on discharge, after 6 weeks and after 6 months, and will include:
- Age, sex, comorbidities (anticoagulation or coagulopathy, dementia, etc)
- Clinical status (cognitive state (orientation in time, place and person), Speech (aphasia/dysarthria), Motor function (hemiplegia/paresis); walking independently (y/n); independence for ADL (y/n); Markwalders Scale, modified Rankin Scale
- Imaging characteristics (location (frontal/parietal/occipital, uni-bilateral), size (max diameter), Density(Hounsfield units, age of hematoma), membranes (y/n). An approximate total of five CTscans will be performed, totaling (5x2=)10mSv of radiation exposure Length of hospital stay will be recorded. The primary endpoint will be the reoperation rate at 40 days. We hypothesize that subdural hematomas treated by minicraniotomy will require less reoperation (reduced to 5%) than burr hole craniostomy or twist drill craniotomy (15 to 25% according to literature).
Secondary endpoints: Clinical endpoints: Duration of operation, technical difficulties during operation. Duration of hospital stay. Improvement of Clinical status and speed thereof, Improvement of CT-imaging characteristics, complication rate (bleeding, local or systemic infection, epilepsy,...). We expect that subdural hematomas operated on by minicraniotomy and large opening of membranes will lead to quicker improvement of CT-imaging than burr hole treatment or twist drill craniotomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All consecutive patients with chronic subdural hematoma with indication for surgical intervention: clinical symptoms as a result of the subdural collection, or important mass effect (as indicated by a midline shift of more than 5mm)
排除标准
- •Patients under the age of 18 will be excluded
- •Patients who have undergone previous cranial surgery which would limit surgical options (for example bone flap already in place)
结局指标
主要结局
Reoperation rate
时间窗: 30 days
The 30 day reoperation rate (number of patients reoperated for recurrence or persistence of chronic subdural hematoma) is the primary endpoint
次要结局
- Mortality(6 months)
- Duration of hospital stay(Number of days the patient is hospitalized after the operation, before he is being discharged home or to a rehabilitation center, an expected average of 2 weeks)
- Improvement of Clinical status and speed thereof(6 months)
- duration of operation(assessment on the day of the surgery; the time duration in minutes from incision (start of the surgery) to finished suturing (end of the surgery) (skin tot skin) is noted)
- Complications(From the moment of hospitalisation till the moment of discharge, an expected average of 2 weeks)
- technical difficulties during operation(during operation (from incision to finished suturing))
- Improvement of Clinical status and speed thereof 2(6 months)
- Improvement of CT-imaging characteristics (Measurement of the largest diameter of the subdural hematoma)(6 months)