UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026255 |
|---|---|
| Receipt number | R000030082 |
| Scientific Title | A randomized controlled trial of reducing effect of postoperative epidural haematoma formation by the use of gelatin hemostatic matrix with human thrombin (FloSeal) in cases with lumbar spinal canal stenosis treated by microendscopic surgery |
| Date of disclosure of the study information | 2017/02/22 |
| Last modified on | 2019/02/25 17:26:37 |
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Basic information
Public title
A randomized controlled trial of reducing effect of postoperative epidural haematoma formation by the use of gelatin hemostatic matrix with human thrombin (FloSeal) in cases with lumbar spinal canal stenosis treated by microendscopic surgery
Acronym
A randomized controlled trial of reducing effect of postoperative epidural haematoma formation by the use of gelatin hemostatic matrix with human thrombin (FloSeal) in cases with lumbar spinal canal stenosis treated by microendscopic surgery
Scientific Title
A randomized controlled trial of reducing effect of postoperative epidural haematoma formation by the use of gelatin hemostatic matrix with human thrombin (FloSeal) in cases with lumbar spinal canal stenosis treated by microendscopic surgery
Scientific Title:Acronym
A randomized controlled trial of reducing effect of postoperative epidural haematoma formation by the use of gelatin hemostatic matrix with human thrombin (FloSeal) in cases with lumbar spinal canal stenosis treated by microendscopic surgery
Region
| Japan |
Condition
Condition
lumbar spinal canal stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the reducing effect of postopertive epidural haematoma formation by the use of gelatin hemostatic matrix with human thrombin (FloSeal) in cases with lumbar spinal canal stenosis treated by microendoscopic surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
quantity of postoperative drainage at 36 hours after surgery
Key secondary outcomes
numerical rating scale(NRS) of postoperative leg pain
size of area of haematoma on the axial image of MRI examined a few days after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
When decompression procedure is finished and operation of hemostasis is completed in microendoscopic spinal surgery, surgeon is told whether the patient belongs to a group of FloSeal or control. If a FloSeal group, FloSeal (5ml) is applied to around dura. After then, drainage is put in surgical field and surgical procedure is finished.
Interventions/Control_2
When decompression procedure is finished and operation of hemostasis is completed in microendoscopic spinal surgery, surgeon is told whether the patient belongs to a group of FloSeal or control. If a control group, drainage is put in surgical field and surgical procedure is finished.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with lumbar spinal canal stenosis who undergo microendoscopic spinal surgery in our hospital
Key exclusion criteria
Patients who have hemorrahagic factors (hemodialysis, liver cirrhosis, etc)
Patients of foraminal stenosis
Patients of re-operation
Patients who suffer dural tear intraoperatively
Patients whose drainage is put unsuitably
Patients who are thought that use of FloSeal is mandatory because of difficulty of hemostasis in the surgical field
Others who are inadequate to current study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanari Takami |
Organization
Wakayama Medical University
Division name
Department of orthopaedic surgery
Zip code
Address
811-1 Kimiidra, Wakayama, Japan
TEL
073-441-0645
maatomo324@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanari Takami |
Organization
Wakayama Medical University
Division name
Department of orthopaedic surgery
Zip code
Address
811-1 Kimiidra, Wakayama, Japan
TEL
073-441-0645
Homepage URL
maatomo324@gmail.com
Sponsor or person
Institute
Department of orthopaedic surgery, Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 21 | Day |
Last modified on
| 2019 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030082
