- 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+Dural expansion
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Time of operation | 2022-04-03 |
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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 | 2022-04-03 |
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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 | 2022-04-03 |
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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 | CH CM |
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Sex | Man
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Age | 55 |
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ID | 8000656836 |
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Hospital number | G86743 |
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Birthplace | 贵州正安县 |
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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 | 2022-04-03 |
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Diagnosis on Admission | 小脑扁桃体下疝畸形 |
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Smoking history | Daily Smoker
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Whether drinking | occasionally
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Family history |
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Medical history |
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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。 |
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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。双侧面部对称。 |
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Chest | 胸廓无畸形，双肺呼吸音粗，未闻及干湿罗音。心率86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 | 颈椎无畸形，四肢无畸形，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 | 意识清楚，精神状态正常。双侧瞳孔等大、等圆，直径3mm，光反射灵敏。双肺呼吸音清晰，心率齐，腹部软，四肢自主活动，肌力、肌张力基本正常，双侧肢体浅感觉正常，双手精细活动正常差。间断性后枕部胀痛，最痛时VAS评分：4-5分。 |
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Hb | 140 g/L |
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RBC | 4.24 X10*12/L |
41.40 % |
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WBC | 6.12 X10*9/L |
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PLT | 258 X10*9/L |
0.23 % |
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Date of test | 2022-04-03 |
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ALT | 11.90 IU/L |
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AST | 11.80 IU/L |
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ADA | U/L |
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GGT | 50.20 U/L |
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Serum bilirubin | 13.60 μmol/L |
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Indirect bilirubin | 11.90 umol/L |
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Direct bilirubin | 1.70 umol/L |
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Serum albumin | 39.30 g/L |
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Serum globulin | 24.60 g/L |
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Serum total protein | 63.90 g/L |
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A/G | 1.60 |
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Date of test | 2022-04-03 yyyy-mm-dd |
Negative
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Date of test | 2022-04-03 yyyy-mm-dd |
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UN | 6.92 mmol/L |
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Cr | 79.20 μmol/L |
mg/L |
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mg/L |
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SOD | U/mL |
88.08 ml/min/l |
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UA | 472.00 μml/L |
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Date of test | 2022-04-03 yyyy-mm-dd |
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ECG | Normal
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Description for the abnormal findings |
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Date of examination | 2022-04-05 yyyy-mm-dd |
Positive
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Type of imaging (s) | / / / |
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Assessment of CT/MRI | 行磁共振(脊柱MR)检查提示：1.颈3/4、颈4/5、颈5/6椎间盘突出（中央型）。2.颈椎退行性变。3.小脑扁桃体下疝。(2022-03-08本院)行ＣＴ(脊柱)检查提示：颈椎退变。颅底凹陷。(2022-02-27 09:40，本院)行磁共振(头颈MR)检查提示：1.垂体前后叶交界处小结节影，考虑Rathke囊肿可能，请结合临床、随访。2.颅底凹陷、小脑扁桃体下疝畸形。 |
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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 | Mild sensory disorder or numbness
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Bladder | Normal
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Total | 16 |
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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 | 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 | Complete remission
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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 | 14 |
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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 | 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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- 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 | 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 limb motor function | Normal
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Lower limb 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 less than 50% of life
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Complications | Persist but well-controlled
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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
|
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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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 |
- 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 | 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 | 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 | No complications
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Total | 16 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 | 2022-04-02 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 |