- 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 | 2022/6/30 |
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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 | 2022-06-25 |
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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 | 2022-06-25 |
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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 | LA XS |
|
Sex | Woman
|
|
Age | 62 |
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ID | 8002837541 |
|
Hospital number | G99781 |
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Birthplace | 四川渠县 |
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Nationality | 汉族 |
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Marital status | married
|
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Occupation | Farmer
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Admission date | 2022-06-25 |
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Diagnosis on Admission | 小脑扁桃体下疝畸形；脊髓空洞 |
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Smoking history | non-smoking history
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Whether drinking | occasionally
|
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Family history | 家族中无传染病及遗传病史 |
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Medical history | 无 |
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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。 |
|
Chest | 胸廓无畸形，双侧乳房呈老女性正常发育，双肺呼吸音清晰，未闻及干湿罗音。心率80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，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，双肺呼吸音清晰，心律齐，腹部软，四肢自主活动，四肢肌力5级，肌张力正常，生理反射存在，病理反射未引出；间断性头部、颈肩部疼痛，呈间断性胀痛，每次持续数分钟左右，自行缓解。 |
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Hb | 83 g/L |
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RBC | 3.81 X10*12/L |
27.90 % |
|
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WBC | 3.91 X10*9/L |
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PLT | 245 X10*9/L |
0.30 % |
|
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Date of test | 2022-06-26 |
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ALT | 9.30 IU/L |
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AST | 19.20 IU/L |
|
ADA | U/L |
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GGT | 11.50 U/L |
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Serum bilirubin | 9.30 μmol/L |
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Indirect bilirubin | 7.60 umol/L |
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Direct bilirubin | 1.70 umol/L |
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Serum albumin | 39.80 g/L |
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Serum globulin | 23.80 g/L |
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Serum total protein | 63.60 g/L |
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A/G | 1.67 |
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Date of test | 2022-06-26 yyyy-mm-dd |
Negative
|
|
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Date of test | 2022-06-26 yyyy-mm-dd |
|
UN | 7.70 mmol/L |
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Cr | 65.30 μmol/L |
mg/L |
|
mg/L |
|
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SOD | U/mL |
84.85 ml/min/l |
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UA | 228.00 μml/L |
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Date of test | 202-06-26 yyyy-mm-dd |
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ECG | Abnormal with clinical significance
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Description for the abnormal findings | 偶发房性早搏，ST段改变，窦性心律 |
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Date of examination | 202-06-23 yyyy-mm-dd |
Positive
|
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Type of imaging (s) | / / / |
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Assessment of CT/MRI | （2022-06-16头颅磁共振，颈椎磁共振）：1双侧侧额叶少许缺血灶，2、小脑扁桃体下疝脊髓空洞形成，3、颈椎退行性变，4、颈椎间盘突出。 |
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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
|
|
Total | 15 |
|
Total | 10 |
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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 | Normal
|
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Bladder | Normal
|
|
Total | 16 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
|
|
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 | 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
|
|
specific description |
|
- Image Examinations
- Symptom
- Complications
- JOA score
- Chicago Chiari Outcome Scale
- Neck Disabilitive 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 | 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
|
|
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 | Normal
|
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bladder | Normal
|
|
Total | 16 分 |
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Pain | Complete remission
|
|
Not painful | Improvement
|
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Function | Can participate in more than 50% of life
|
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Complications | No complications
|
|
Total | 14 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
|
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Occipital and neck pain | Yes
|
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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
|
|
specific description |
|
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Upper extremity motor function | Normal
|
|
Lower extremity motor function | Normal
|
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Upper limb sensory function | Normal
|
|
Lower limb sensory function | Normal
|
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Trunk sensory function | Mild sensory disorder or numbness
|
|
Bladder | Normal
|
|
Total | 16 分 |
|
Pain | Improvement
|
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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 | No complications
|
|
Total | 14 分 |
|
Total | 9 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
|
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Whether to perform the spine MRI | NO
|
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Occipital and neck pain | Yes
|
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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
|
|
specific description |
|
|
Upper extremity motor function | Normal
|
|
Lower extremity motor function | Normal
|
|
Upper limb sensory function | Normal
|
|
Lower limb sensory function | Normal
|
|
Torso sensory function | Mild sensory disorder or numbness
|
|
Bladder | Normal
|
|
Total | 16 分 |
|
Pain | Improvement
|
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Not painful | Complete remission
|
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Function | Can participate in more than 50% of life
|
|
Complications | No complications
|
|
Total | 14 分 |
|
Total | 16 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 | Yes
|
|
Occipital and neck pain | Yes
|
|
Body or limbs feel abnormal | NO
|
|
Limb muscle strength decreased | NO
|
|
Dizziness pain | NO
|
|
Bowel and bladder dysfunction | NO
|
|
Sexual dysfunction | NO
|
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Autonomic nervous system dysfunction | NO
|
|
With or without complications | Yes
|
|
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 | Normal
|
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Torso sensory function | Have a clear sensory disorder
|
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Bladder | Normal
|
|
Total | 15 分 |
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Pain | Improvement
|
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Not painful | Complete remission
|
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Function | Completely normal
|
|
Complications | No complications
|
|
Total | 15 分 |
|
Total | 16 分 |
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Whether got the informed consent? | Yes
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Date of sign the informed consent | 2022/6/29 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 |