- 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
|
Operation method | Posterior cranial fossa decompression(2×3cm area including posterior arch of atlas and foramen magnum)+Dural "Y" type incision+Dural expansion
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Time of operation | 2022/9/6 |
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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 | 2022-09-02 |
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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 | 2022-09-02 |
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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
|
Name | RA HO |
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Sex | Man
|
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Age | 30 |
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ID | 8003801237 |
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Hospital number | H13554 |
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Birthplace | 贵州省 |
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Nationality | 土家族 |
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Marital status | married
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Occupation | Worker
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Admission date | 2022-09-02 |
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Diagnosis on Admission | 1、小脑扁桃体下疝畸形； 2、脊髓空洞症； 3、颈椎退行性变 |
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Smoking history | Seeking smoking
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Whether drinking | Never
|
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Family history | 父母健在，子女健康状况良好，家族中无传染病及遗传病史。 |
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Medical history | 曾于0年前受伤 |
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General condition | 精神可，意识清楚，对答切题，自己步入病房。 |
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Skin and lymph nodes | 皮肤粘膜正常，无黄染、无出血点、无蜘蛛痣、无瘀点瘀斑、无皮疹，皮肤弹性正常，皮肤温度湿度正常，皮肤无疤痕，皮肤未见明显水肿。全身浅表淋巴结未扪及肿大。 |
|
Head and neck region | 头颅无畸形，无压痛，面容正常，鼻窦区、乳突区无压痛，耳鼻无异常渗液，嘴唇增厚，鼻部增大，颈对称，颈静脉正常，气管居中，甲状腺正常、未触及明显震颤、未闻及明显血管杂音,颈部血管无杂音。 |
|
Chest | 胸廓对称无畸形，胸壁静脉不显露，胸壁无肿块，肋间隙正常，肋骨挤压试验阴性，胸骨无压痛。正常呼吸，呼吸动度两侧对称，双肺语颤正常两侧对称，双肺叩诊清音对称，双肺呼吸清晰对称，无附加呼吸音。心率85次/分，心律规则，心脏各瓣膜未闻及病理性杂音。 |
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Abdomen | 腹部正常，腹部左右对称，腹壁静脉无扩张，腹部软无压痛，肝肋缘下未扪及，脾肋缘下未扪及，肝脾区无叩痛，全腹未触及包块，肾区无叩击痛，腹部移动性浊音阴性，肠鸣音正常，5-6次/分，腹部未闻及明显血管杂音。 |
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Spine and limbs | 脊柱生理曲度正常，脊柱四肢无压痛，活动基本正常，无畸形、下肢静脉曲张、杵状指（趾）。 |
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Nervous system examination | 意识清楚，言语清晰流利，精神可，查体合作，双侧瞳孔等大等圆，直径约3.0mm，对光反射灵敏，颈软，左上肢麻木症状明显，伴有疼痛及颈后部疼痛，双肺未闻及干湿罗音，自觉头昏、左上肢偶乏力，肢体肌力约5级，肌张力正常，病理征阴性。 |
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Hb | 149 g/L |
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RBC | 5.53 X10*12/L |
44.8 % |
|
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WBC | 6.30 X10*9/L |
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PLT | 265 X10*9/L |
0.29 % |
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Date of test | 2022-09-03 |
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ALT | 31.60 IU/L |
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AST | 28.80 IU/L |
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ADA | U/L |
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GGT | 121.20 U/L |
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Serum bilirubin | 12.30 μmol/L |
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Indirect bilirubin | 10.20 umol/L |
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Direct bilirubin | 2.10 umol/L |
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Serum albumin | 42.30 g/L |
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Serum globulin | 27.20 g/L |
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Serum total protein | 69.50 g/L |
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A/G | 1.56 |
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Date of test | 2022-09-03 yyyy-mm-dd |
Negative
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|
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Date of test | 2022-09-03 yyyy-mm-dd |
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UN | 4.26 mmol/L |
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Cr | 81.20 μmol/L |
mg/L |
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mg/L |
|
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SOD | U/mL |
96.79 ml/min/l |
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UA | 385.00 μml/L |
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Date of test | 2022-09-03 yyyy-mm-dd |
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ECG | Abnormal with clinical significance
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Description for the abnormal findings | 完全性右束支阻滞，电轴右偏 |
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Date of examination | 2022-09-02 yyyy-mm-dd |
Positive
|
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Type of imaging (s) | / / / |
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Assessment of CT/MRI | 颈椎MRI示小脑扁桃体下疝畸形、脊髓空洞症。 |
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Upper extremity motor function | Usually you can eat with chopsticks, but not flexible
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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 | Normal
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Bladder | Normal
|
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Total | 15 |
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Total | 9 |
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Upper extremity motor function | Usually you can eat with chopsticks, but not flexible
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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 | Normal
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Bladder | Normal
|
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Total | 15 分 |
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Pain | Complete remission
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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 | 13 |
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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 | Yes
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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 |
|
- Image Examinations
- Symptom
- Complications
- JOA score
- Chicago Chiari Outcome Scale
- Neck Disabilitive 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 | 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 | Yes
|
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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 limb motor function | Usually you can eat with chopsticks, but not flexible
|
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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 | Normal
|
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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
|
|
Total | 12 分 |
|
Total | 0 分 |
- Image Examinations
- Symptom
- Complications
- JOA score
- Chicago Chiari Outcome Scale
- Neck Disabilitve Index NDI
|
Whether to perform the chest CT | NO
|
|
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 | Yes
|
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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
|
|
specific description |
|
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Upper extremity motor function | Usually you can eat with chopsticks, but not flexible
|
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Lower extremity motor function | Normal
|
|
Upper limb sensory function | Mild sensory disorder or numbness
|
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Lower limb sensory function | Normal
|
|
Trunk sensory function | Normal
|
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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 more than 50% of life
|
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Complications | No complications
|
|
Total | 13 分 |
|
Total | 0 分 |
- Image Examinations
- Symptom
- Complications
- JOA score
- Chicago Chiari Outcome Scale
- Neck Disabilitve Index NDI
|
Whether to perform the chest CT | NO
|
|
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
|
|
Occipital and neck pain | No
|
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Body or limbs feel abnormal | Yes
|
|
Limb muscle strength decreased | No
|
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Dizziness pain | No
|
|
Bowel and bladder dysfunction | No
|
|
Sexual dysfunction | No
|
|
Autonomic nervous system dysfunction | No
|
|
With or without complications | No
|
|
specific description |
|
|
Upper extremity motor function | Normal
|
|
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 | Normal
|
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Bladder | Normal
|
|
Total | 16 分 |
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Pain | Remain the same
|
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Not painful | Remain the same
|
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Function | Completely normal
|
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Complications | No complications
|
|
Total | 12 分 |
|
Total | 0 分 |
- Image Examinations
- Symptom
- Complications
- JOA score
- Chicago Chiari Outcome Scale
- Neck Disabilitve Index NDI
|
Whether to perform the chest CT | NO
|
|
Whether to perform the head and neck CT | NO
|
|
Whether to perform the spine CT | NO
|
|
Whether to perform the spine MRI | NO
|
|
Occipital and neck pain | NO
|
|
Body or limbs feel abnormal | Yes
|
|
Limb muscle strength decreased | NO
|
|
Dizziness pain | NO
|
|
Bowel and bladder dysfunction | NO
|
|
Sexual dysfunction | NO
|
|
Autonomic nervous system dysfunction | NO
|
|
With or without complications | NO
|
|
Specific description |
|
|
Upper extremity motor function | Normal
|
|
Lower extremity motor function | Normal
|
|
Upper limb sensory function | Mild sensory disorder or numbness
|
|
Lower limb sensory | Normal
|
|
Torso sensory function | Normal
|
|
Bladder | Normal
|
|
Total | 16 分 |
|
Pain | Remain the same
|
|
Not painful | Remain the same
|
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Function | Completely normal
|
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Complications | No complications
|
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Total | 12 分 |
|
Total | 0 分 |
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Whether got the informed consent? | Yes
|
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Date of sign the informed consent | 2022/9/6 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 |
|
Jiangkai Lin | |
|
Weihua Chu | |
|
Guangjian He | |
|
Xingsen Xue | |
|
Xin Chen | |
|
Na Wu |