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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021769
Receipt No. R000025056
Scientific Title Usefulness of dexmedetomidine for endoscopic submucosal dissection in colon
Date of disclosure of the study information 2016/04/07
Last modified on 2018/01/14

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Basic information
Public title Usefulness of dexmedetomidine for endoscopic submucosal dissection in colon
Acronym Usefulness of dexmedetomidine for endoscopic submucosal dissection in colon
Scientific Title Usefulness of dexmedetomidine for endoscopic submucosal dissection in colon
Scientific Title:Acronym Usefulness of dexmedetomidine for endoscopic submucosal dissection in colon
Region
Japan

Condition
Condition colorectal tumor
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Usefulness of dexmedetomidine for endoscopic submucosal dissection in colon
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Satisfaction in patient
Key secondary outcomes Patients' pain level (VAS)
Endoscopists' satisfaction (VAS)
Objective patients' pain level viewed from endoscopists (VAS)
Movement (VAS)
Difficulty (VAS)
Rate of response
Rate of en bloc
Rate of R0 resection
Resection time
Resected section diameter
Total amount of analgesic
Rate of side effects
Rate of complications

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 dexmedetomidine
Interventions/Control_2 placebo
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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients for whom ESD in colon will be performed
2)Patients who have provided written informed consent for participation in this study
Key exclusion criteria Patients judged by the principal investigator or subinvestigator to be unsuitable for participation for any other reason (to ensure the safe conduct of this study)
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Kinugasa
Organization Hiroshima City Hiroshima Citizens Hospital
Division name Internal medicine
Zip code
Address 7-33 Motomachi, Naka-ku, Hiroshima-shi, Hiroshima-ken, Japan
TEL 082-221-2291
Email gyacy14@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Kinugasa
Organization Hiroshima City Hiroshima Citizens Hospital
Division name Internal medicine
Zip code
Address 7-33 Motomachi, Naka-ku, Hiroshima-shi, Hiroshima-ken, Japan
TEL 082-221-2291
Homepage URL
Email gyacy14@gmail.com

Sponsor
Institute Hiroshima City Hiroshima Citizens Hospital
Institute
Department

Funding Source
Organization Hiroshima City Hiroshima Citizens Hospital
Organization
Division
Category of Funding Organization Other
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
2016 Year 04 Month 07 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
2016 Year 04 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 07 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
2016 Year 04 Month 04 Day
Last modified on
2018 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025056

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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