- In the process of the treatment
- Screening
- Baseline
- Follow-up（One week after surgery）
- Follow-up （One month after surgery）
- Follow-up （Three months after surgery）
- Follow-up （Six months after surgery）
- Follow-up （One year after surgery）
- Management and ethics documents
- ADR/ADE management system
- Research team
- Design, Methods
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Operation method | Posterior cranial fossa decompression(2×3cm area including posterior arch of atlas and foramen magnum)+Dural "Y" type incision+Cerebellar tonsillectomy and adhesions+Dural expansion
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Time of operation | 2022-05-12 |
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ChiariⅠmalformation confirmed by MR imaging, have corresponding clinical symptoms and signs | Yes
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All genders, age from 18-70 years old | Yes
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Signed informed consent | Yes
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Doctor | 林江凯 |
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Date | 2022-05-10 |
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Congenital diseases, psychotic or neurotic diseases, serious diseases of heart,lung,liver or kidney. | No
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Other Chiari malformations, or Chiari Ⅰmalformations combined with basilar invagination, atlantoaxial dislocation or scoliosis | No
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Other cervical diseases(such as tumor,trauma and degeneration) resulted in cervical pain, limbs numbness or weekness, sphincter disturbance or sexual dysfunction. | No
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Recently(<3y) drug using or psychological problems that could affect outcome | No
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Attned other clinical trials in last 3 monthes | No
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Pregnant women | No
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Doctor | 林江凯 |
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Date | 2022-05-10 |
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The patient does not cooperate with this study | |
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The patient died | |
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The patient asked to quit | |
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Doctor |
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Date |
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- General information
- Physical examination
- Nervous system examination
- Blood Routine Tests
- Serum Liver Function Tests
- HBV Markers Test
- Renel Function Test
- ECG
- Blood type
- Image Examinations
- Preoperative JOA score
- Neck Disabilitve Index NDI
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Name | YA BY |
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Sex | Man
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Age | 57 |
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ID | 8003623877 |
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Hospital number | G94100 |
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Birthplace | 重庆市 |
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Nationality | 汉族 |
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Marital status | married
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Occupation | Worker
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Admission date | 2022-05-10 |
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Diagnosis on Admission | 1、小脑扁桃体下疝畸形；2、脊髓空洞症；3、左侧小脑半球外侧后颅窝区蛛网膜囊肿；4、C3/4、C4/5、C5/6椎间盘突出（中央型）；5、高血压病 2级 高危组。 |
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Smoking history | Daily Smoker
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Whether drinking | Often
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Family history | 家族中无传染病及遗传病史 |
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Medical history | 2年前患者于当地医院诊断“高血压病”，收缩压最高达170mmHg，平素口服苯磺酸氨氯地平 1片/日控制血压。 |
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General condition | 步入病区，神志清晰，自主体位，查体合作。 |
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Skin and lymph nodes | 皮肤巩膜无黄染，全身浅表淋巴结无肿大。 |
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Head and neck region | 头颅未见明显畸形，未及明显头皮包块、颅骨凹陷等，颈部对称，耳、鼻未见漏液，未见颈静脉怒张，唇无发绀，甲状腺不大，气管居中。 |
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Chest | 胸廓无畸形，双侧乳房呈男性正常发育，双肺呼吸音粗，未闻及干湿罗音。心率81次／分，心律齐，各瓣膜听诊区未闻及病理性杂音。 |
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Abdomen | 全腹软，未见胃肠型及蠕动波，肝脾肋下未触及，移动性浊音阴性，肠鸣音正常。 |
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Spine and limbs | 脊柱外观未见明显异常，四肢未见肌肉萎缩，全身各关节活动未见明显受限，双下肢无水肿。 |
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Nervous system examination | 神志可，言语清晰，颈肩部不适感，对答切题，查体合作，双侧瞳孔等大等圆，直径约3mm，光反应灵敏，颈软，左手掌麻木，双上肢肌张力正常，四肢肌力、肌张力基本正常，生理反射存在，病理反射未引出。 |
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Hb | 153 g/L |
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RBC | 4.96 X10*12/L |
45.80 % |
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WBC | 9.51 X10*9/L |
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PLT | 196 X10*9/L |
0.23 % |
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Date of test | 2022-05-11 |
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ALT | 50.50 IU/L |
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AST | 31.40 IU/L |
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ADA | U/L |
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GGT | 49.80 U/L |
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Serum bilirubin | 9.30 μmol/L |
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Indirect bilirubin | 8.20 umol/L |
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Direct bilirubin | 1.10 umol/L |
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Serum albumin | 42.80 g/L |
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Serum globulin | 26.70 g/L |
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Serum total protein | 69.50 g/L |
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A/G | 1.60 |
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Date of test | 2022-05-11 yyyy-mm-dd |
Negative
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Date of test | 2022-05-11 yyyy-mm-dd |
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UN | 4.24 mmol/L |
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Cr | 65.20 μmol/L |
mg/L |
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mg/L |
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SOD | U/mL |
109.45 ml/min/l |
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UA | 469.00 μml/L |
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Date of test | 2022-05-11 yyyy-mm-dd |
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ECG | Abnormal but no clinical significance
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Description for the abnormal findings | 1.窦性心律；2.电轴左偏。 |
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Date of examination | 2022-05-06 yyyy-mm-dd |
Positive
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Type of imaging (s) | / / / |
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Assessment of CT/MRI | (头颈MR)检查提示：1.小脑扁桃体下疝，左侧小脑半球外侧后颅窝区蛛网膜囊肿，幕上脑室梗阻性稍扩张积水。2.左侧脑室周围可能为血管起源的白质高信号（Fazekas 1级）。3.右侧蝶窦、后组筛窦小囊肿，双侧筛窦炎。(2022-04-28 15:23，本院)行磁共振(脊柱MR)检查提示：1.颈3/4、颈4/5、颈5/6椎间盘变性、突出（中央型）。2.小脑扁桃体下疝，脊髓空洞。3.脊柱退行性变。(2022-05-07 22:26，本院)行ＣＴ(脊柱)检查提示：1.小脑扁桃体下疝，左侧小脑半球外侧后颅窝区蛛网膜囊肿；2.寰齿关节边缘骨质增生，环齿关节间隙左右不对称。3.颈椎生理曲度变直，颈4椎体前缘少许积气。(2022-05-07 19:34，本院)行ＣＴ(胸腹部)检查提示：1.双肺多发增殖灶，Lung-RADS 3级，建议6个月随诊复查。2.左肺下叶钙化灶。3.主动脉及左侧冠状动脉硬化。 |
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Upper extremity motor function | Normal
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Lower extremity motor function | Normal
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Upper limb sensory function | Mild sensory disorder or numbness
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Lower limb sensory function | Normal
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Torso sensory function | Mild sensory disorder or numbness
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Bladder | Normal
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Total | 15 |
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Total | 0 |
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Upper extremity motor function | Normal
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Lower extremity motor function | Normal
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Upper limb sensory functio | Mild sensory disorder or numbness
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Lower limb sensory function | Normal
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Torso sensory function | Mild sensory disorder or numbness
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Bladder | Normal
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Total | 15 分 |
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Pain | Improvement
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Not painful | Improvement
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Function | Can participate in less than 50% of life
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Complications | No complications
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Total | 12 |
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Whether to perform the chest CT | NO
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Whether to perform the head and neck CT | NO
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Whether to perform the spine CT | NO
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Whether to perform the spine MRI | Yes
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Occipital and neck pain | No
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Body or limbs feel abnormal | Yes
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Limb muscle strength decreased | NO
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Dizziness pain | NO
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Bowel and bladder dysfunction | NO
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Sexual dysfunction | NO
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Autonomic nervous system dysfunction | NO
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With or without complications | NO
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specific description |
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- Image Examinations
- Symptom
- Complications
- JOA score
- Chicago Chiari Outcome Scale
- Neck Disabilitive Index NDI
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Whether to perform the chest CT | NO
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Whether to perform the head and neck CT | No
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Whether to perform the spine CT | No
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Whether to perform the spine MRI | No
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Occipital and neck pain | No
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Body or limbs feel abnormal | Yes
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Limb muscle strength decreased | No
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Dizziness pain | Yes
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Bowel and bladder dysfunction | No
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Sexual dysfunction | No
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Autonomic nervous system dysfunction | No
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With or without complications | No
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specific description |
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Upper limb motor function | Normal
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Lower limb motor function | Normal
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Upper limb sensory function | Mild sensory disorder or numbness
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Lower limb sensory function | Normal
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Trunk sensory function | Mild sensory disorder or numbness
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bladder | Normal
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Total | 15 分 |
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Pain | Improvement
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Not painful | Improvement
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Function | Can participate in less than 50% of life
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Complications | No complications
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Total | 12 分 |
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Total | 0 分 |
- Image Examinations
- Symptom
- Complications
- JOA score
- Chicago Chiari Outcome Scale
- Neck Disabilitve Index NDI
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Whether to perform the chest CT | NO
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Whether to perform the head and neck CT | No
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Whether to perform the spine CT | No
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Whether to perform the spine MRI | No
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Occipital and neck pain | No
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Body or limbs feel abnormal | No
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Limb muscle strength decreased | No
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Dizziness pain | No
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Bowel and bladder dysfunction | No
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Sexual dysfunction | No
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Autonomic nervous system dysfunction | No
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With or without complications | Yes
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specific description | 伤口疼痛 |
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Upper extremity motor function | Normal
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Lower extremity motor function | Normal
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Upper limb sensory function | Normal
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Lower limb sensory function | Normal
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Trunk sensory function | Normal
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Bladder | Normal
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Total | 17 分 |
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Pain | Complete remission
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Not painful | Complete remission
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Function | Can participate in more than 50% of life
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Complications | Persist but well-controlled
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Total | 13 分 |
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Total | 0 分 |
- Image Examinations
- Symptom
- Complications
- JOA score
- Chicago Chiari Outcome Scale
- Neck Disabilitve Index NDI
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Whether to perform the chest CT | NO
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Whether to perform the head and neck CT | NO
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Whether to perform the spine CT | NO
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Whether to perform the spine MRI | NO
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Occipital and neck pain | No
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Body or limbs feel abnormal | No
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Limb muscle strength decreased | No
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Dizziness pain | No
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Bowel and bladder dysfunction | No
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Sexual dysfunction | No
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Autonomic nervous system dysfunction | No
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With or without complications | No
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specific description |
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Upper extremity motor function | Normal
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Lower extremity motor function | Normal
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Upper limb sensory function | Normal
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Lower limb sensory function | Normal
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Torso sensory function | Normal
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Bladder | Normal
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Total | 17 分 |
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Pain | Complete remission
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Not painful | Improvement
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Function | Completely normal
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Complications | No complications
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Total | 15 分 |
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Total | 0 分 |
- Image Examinations
- Symptom
- Complications
- JOA score
- Chicago Chiari Outcome Scale
- Neck Disabilitve Index NDI
|
Whether to perform the chest CT | NO
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Whether to perform the head and neck CT | NO
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Whether to perform the spine CT | NO
|
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Whether to perform the spine MRI | Yes
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Occipital and neck pain | NO
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Body or limbs feel abnormal | NO
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Limb muscle strength decreased | NO
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Dizziness pain | NO
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Bowel and bladder dysfunction | NO
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Sexual dysfunction | NO
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Autonomic nervous system dysfunction | NO
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With or without complications | Yes
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Specific description | 皮下积液 |
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Upper extremity motor function | Normal
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Lower extremity motor function | Normal
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Upper limb sensory function | Normal
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Lower limb sensory | Normal
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Torso sensory function | Normal
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Bladder | Normal
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Total | 17 分 |
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Pain | Complete remission
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Not painful | Complete remission
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Function | Completely normal
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Complications | Persist but well-controlled
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Total | 14 分 |
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Total | 0 分 |
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Whether got the informed consent? | Yes
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Date of sign the informed consent | 2022-05-11 xx年xx月xx日 |
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Types of violation | |
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Informed consent violant | |
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No. of the violance |
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Date of violance | yyyy-mm-dd-hh-min. |
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Inclusion and Exclusion criteria violation | |
yyyy-mm-dd-hh-min. |
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yyyy-mm-dd-hh-min. |
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Adverse events violantion | |
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yyyy-mm-dd-hh-min. |
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Follow-up violation | |
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yyyy-mm-dd-hh-min. |
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Loss of data violation | |
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yyyy-mm-dd-hh-min. |
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Data over the feild violation | |
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yyyy-mm-dd-hh-min. |
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Therapy or operation compliance violation | |
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yyyy-mm-dd-hh-min. |
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Any approach | |
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Date of action | yyyy-mm-dd-hh-min. |
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Violation information |
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Name of adverse event |
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Reason of adverse event |
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Start date | yyyymmdd |
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Interventions | |
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Interventions, please specify |
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Start date | yyyymmdd |
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Stop date | yyyymmdd |
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Attributed to the surgical plan | |
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Outcome of the event | |
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If recovered/resolved, the date is | yyyymmdd |
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Name of the recorder |
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Data | yyyymmdd |
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Site Investigator’s signature |
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Data | yyyymmdd |
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Southwest Hospital |
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Jiangkai Lin | |
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Weihua Chu | |
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Guangjian He | |
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Xingsen Xue | |
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Xin Chen | |
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Na Wu |