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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name