- 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 | 2022/9/13 |
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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 |
|
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 | RE CL |
|
Sex | Woman
|
|
Age | 48 |
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ID | 123254100 |
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Hospital number | H13181 |
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Birthplace | 重庆彭水苗族土家族自治县 |
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Nationality | 汉 |
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Marital status | married
|
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Occupation | Farmer
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Admission date | 2022-09-02 |
|
Diagnosis on Admission | 1.小脑扁桃体下疝畸形；2.脊髓空洞；3.颈3/4-颈5/6椎间盘膨出；4.腰4椎体前滑脱（Ⅰ°）；5.腰4/5椎间盘膨出；6.骶部皮下筋膜炎 |
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Smoking history | non-smoking history
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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。 |
|
Medical history | 无 |
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General condition | 步入病区，神志清晰，智力正常，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。 |
|
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。双侧面部对称。 |
|
Chest | 胸廓无畸形，双肺呼吸音清晰，未闻及干湿罗音。心率73次／分，心律齐，各瓣膜听诊区未闻及病理性杂音。 |
|
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、四肢无畸形，左手无名指、小指关节伸展障碍，右手小指伸展障碍，全身其它各关节活动未见明显受限，双下肢无水肿。 |
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Nervous system examination | 意识清楚，精神状态较好。双侧瞳孔等待、等圆，光反射灵敏。四肢可按吩咐活动，上下楼梯觉双腿发软，稳定性变差，双上肢肌力5级，双下肢肌力4+级。左大小鱼际肌、拇指-食指指间肌萎缩，双侧小指肌肉挛缩，伸展障碍。龙伯氏（Romberg）征：阳性。颈软。 |
|
Hb | 101 g/L |
|
RBC | 3.85 X10*12/L |
32.50 % |
|
|
WBC | 3.21 X10*9/L |
|
PLT | 168 X10*9/L |
0.20 % |
|
|
Date of test | 2022-09-03 |
|
ALT | 37.70 IU/L |
|
AST | 40.50 IU/L |
|
ADA | U/L |
|
GGT | 51.20 U/L |
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Serum bilirubin | 8.80 μmol/L |
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Indirect bilirubin | 7.00 umol/L |
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Direct bilirubin | 1.80 umol/L |
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Serum albumin | 36.30 g/L |
|
Serum globulin | 25.10 g/L |
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Serum total protein | 61.40 g/L |
|
A/G | 1.45 |
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Date of test | 2022-09-03 yyyy-mm-dd |
Negative
|
|
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Date of test | 2022-09-03 yyyy-mm-dd |
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UN | 6.04 mmol/L |
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Cr | 53.00 μmol/L |
mg/L |
|
mg/L |
|
|
SOD | U/mL |
113.72 ml/min/l |
|
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UA | 347.00 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 | 窦性心律，逆钟向转位。 |
|
Date of examination | 2022-09-03 yyyy-mm-dd |
Positive
|
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Type of imaging (s) | / / / |
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Assessment of CT/MRI | MRI示：小脑扁桃体位置下移，颈4-5椎体节段脊髓见线样T2高信号，颈7-胸1节段脊髓见梭性T1低信号、T2高信号影。骶部皮下筋膜见片状T2高信号。椎体边缘骨质增生，腰4椎体稍向前移位。部分椎间盘信号减低；颈3/4-颈5/6椎间盘轻度膨出；腰4/5椎间盘向周围膨出，双侧椎间孔变窄，神经根受压。 |
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Upper extremity motor function | Barely can eat with chopsticks
|
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Lower extremity motor function | Take a walking stick or other support
|
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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 | Mild sensory disorder or numbness
|
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Bladder | Normal
|
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Total | 10 |
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Total | 0 |
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Upper extremity motor function | ?Barely can eat with chopsticks
|
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Lower extremity motor function | Take a walking stick or other support
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Upper limb sensory functio | Normal
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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 | 10 分 |
|
Pain | Remain the same
|
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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 | 11 |
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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
|
|
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
|
|
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 limb motor function | Barely can eat with chopsticks
|
|
Lower limb motor function | Take a walking stick or other support
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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 | 10 分 |
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Pain | Remain the same
|
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Not painful | Remain the same
|
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Function | Can participate in less than 50% of life
|
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Complications | No complications
|
|
Total | 10 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
|
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Whether to perform the spine MRI | No
|
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Occipital and neck pain | No
|
|
Body or limbs feel abnormal | Yes
|
|
Limb muscle strength decreased | Yes
|
|
Dizziness pain | No
|
|
Bowel and bladder dysfunction | No
|
|
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 | Barely can eat with chopsticks
|
|
Lower extremity motor function | Take a walking stick or other support
|
|
Upper limb sensory function | Normal
|
|
Lower limb sensory function | Normal
|
|
Trunk sensory function | Mild sensory disorder or numbness
|
|
Bladder | Normal
|
|
Total | 10 分 |
|
Pain | Remain the same
|
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Not painful | Remain the same
|
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Function | Can participate in more than 50% of life
|
|
Complications | No complications
|
|
Total | 11 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
|
|
Occipital and neck pain | No
|
|
Body or limbs feel abnormal | Yes
|
|
Limb muscle strength decreased | Yes
|
|
Dizziness pain | No
|
|
Bowel and bladder dysfunction | No
|
|
Sexual dysfunction | No
|
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Autonomic nervous system dysfunction | No
|
|
With or without complications | No
|
|
specific description |
|
|
Upper extremity motor function | Barely can eat with chopsticks
|
|
Lower extremity motor function | Flat without a cane or other supports, but up and down stairs
|
|
Upper limb sensory function | Normal
|
|
Lower limb sensory function | Normal
|
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Torso sensory function | Mild sensory disorder or numbness
|
|
Bladder | Normal
|
|
Total | 12 分 |
|
Pain | Remain the same
|
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Not painful | Exacerbation
|
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Function | Can participate in more than 50% of life
|
|
Complications | No complications
|
|
Total | 10 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 | Yes
|
|
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 | Barely can eat with chopsticks
|
|
Lower extremity motor function | Flat without a cane or other supports, but up and down stairs
|
|
Upper limb sensory function | Normal
|
|
Lower limb sensory | Normal
|
|
Torso sensory function | Mild sensory disorder or numbness
|
|
Bladder | Normal
|
|
Total | 12 分 |
|
Pain | Remain the same
|
|
Not painful | Exacerbation
|
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Function | Can participate in more than 50% of life
|
|
Complications | No complications
|
|
Total | 10 分 |
|
Total | 0 分 |
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Whether got the informed consent? | Yes
|
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Date of sign the informed consent | 2022/9/13 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 |