UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
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	Masanari Takami
Organization	Wakayama Medical University
Division name	Department of orthopaedic surgery
Address	811-1 Kimiidra, Wakayama, Japan
TEL	073-441-0645
Email	maatomo324@gmail.com

Public contact
Name of contact person	Masanari Takami
Organization	Wakayama Medical University
Division name	Department of orthopaedic surgery
Address	811-1 Kimiidra, Wakayama, Japan
TEL	073-441-0645
Homepage URL
Email	maatomo324@gmail.com

Sponsor
Institute	Department of orthopaedic surgery, Wakayama Medical University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030082