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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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TCTR |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
TCTR20150226001 |
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Date of registration:
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26/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of preoperative systemic steroid injection on prevertebral soft tissue swelling following anterior cervical discectomy and fusion(ACDF)
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Scientific title:
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Effect of preoperative systemic steroid injection on prevertebral soft tissue swelling following anterior cervical discectomy and fusion(ACDF) |
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Date of first enrolment:
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17/02/2015 |
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Target sample size:
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64 |
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Recruitment status: |
Pending (Not yet recruiting) |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20150226001 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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Phase 4
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Nuttawut -
Rodjanasirisawat |
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Address:
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Orthopaedic department PSU hospital
90110
Songkla
Thailand |
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Telephone:
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0846310080 |
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Email:
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donutted072@gmail.com |
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Affiliation:
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PSU |
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Name:
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Nuttawut -
Rodjanasirisawat |
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Address:
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Orthopaedic department PSU hospital
90110
Songkla
Thailand |
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Telephone:
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0846310080 |
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Email:
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donutted072@gmail.com |
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Affiliation:
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PSU |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patient with age more than 18 year old
Patient underwent ACDF in 1-2 level in PSU hospital
Inform consent
Exclusion criteria: Revision surgery
Chronic used of steroid
Drug allergy or contraindication of steroid
Pregnancy
Age minimum:
18 Years
Age maximum:
100 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cervical spondylotic myelopathy
Cervical spondylotic radicilopathy
Prevertebral soft tissue swelling
Steroid
Prevertebral soft tissue swelling
Anterior cervical discectomy and fusion
ACDF
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Steroid
Prevertebral soft tissue swelling
Anterior cervical discectomy and fusion
ACDF
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Intervention(s)
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Dexamethasone 10 mg IV injection by anestheologist at 60 min before surgery,Placebo (Normal salinr 10 ml) IV injection by anestheologist at 60 min before surgery
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Experimental Drug,Placebo Comparator Drug
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Steroid injection group,Placebo group
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Primary Outcome(s)
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PSTS ratio(S/V) - Plain flim lateral C-spine,PSTS index - Plain flim lateral C-spine
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Secondary Outcome(s)
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Odynophagia - using visual analogue scale(VAS),Dysphagia - Bazaz disphagia questionnaire,Japanese orthopedic association score(JOA score) for CSM - JOA score form,Neck disability index(NDI) for CSR - NDI form
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Secondary ID(s)
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57-346-11-1
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Source(s) of Monetary Support
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PSU hospital
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Ethics review
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Status:
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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17/02/2016 |
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URL:
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