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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024733
Receipt No. R000027633
Scientific Title Inhibitory effect of lidocaine on colon spasm: A multicenter double-blind, randomized controlled trial
Date of disclosure of the study information 2016/11/08
Last modified on 2019/06/13

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Basic information
Public title Inhibitory effect of lidocaine on colon spasm: A multicenter double-blind, randomized controlled trial
Acronym LIDO Study
Scientific Title Inhibitory effect of lidocaine on colon spasm: A multicenter double-blind, randomized controlled trial
Scientific Title:Acronym LIDO Study
Region
Japan

Condition
Condition Patients receiving colonoscopy for endoscopic resection of colorectal lesions
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify inhibitory effect and safety of topical lidocaine on colonic spasms during colonoscopy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes inhibitory effect on intestinal spasm
Key secondary outcomes rebound spasm, symptom associated with the dispersion, adverse event, blood level of lidocaine

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 dispersion of 2% lidocaine solution 20mL
Interventions/Control_2 dispersion of saline 20mL
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria patients with colorectal lesions scheduled for endoscopic resection
Key exclusion criteria hypersensitivity to lidocaine
inflammatory bowel disease, i.e., ulcerative colitis, crohn disease
intestinal dysfunction, e.g., pseudo-obstruction
females with pregnancy or suspicion
history of colorectal resection
Target sample size 128

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutomo Togashi
Organization Aizu Medical Center, Fukushima MEdical University
Division name Department of Coloproctology
Zip code
Address Aizuwakamatsu-city
TEL 0242-75-2100
Email togashik@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jinko Kobayashi
Organization Aizu Medical Center, Fukushima Medical University
Division name Department of Coloproctology
Zip code
Address Aizuwakamatsu-city
TEL 0242-75-2100
Homepage URL
Email togashik@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Department of Coloproctology, Aizu Medical Center, Fukushima Medicaal University
Organization
Division
Category of Funding Organization Local Government
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 YES
Study ID_1 2801
Org. issuing International ID_1 Fukushima Medical University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 福島県立医科大学会津医療センター(福島県)、大阪府立成人病センター(大阪府)、小樽掖済会病院消化器センター(北海道)、国立病院機構東京医療センター(東京都)、仙台厚生病院消化器内視鏡センター(宮城県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 08 Day

Related information
URL releasing protocol doi: 10.1111/den.13272. Epub 2018 Oct 17. PubMed PMID: 30187572.
Publication of results Published

Result
URL related to results and publications doi: 10.1111/den.13272. Epub 2018 Oct 17. PubMed PMID: 30187572.
Number of participants that the trial has enrolled 128
Results
with "excellent" scores was greater in LID group than control group, with significant differences observed at 2 minutes (p = 0.02) and 3 minutes (p = 0.02). In LID group, the rate of "excellent" scores increased by 12.5% at 2 minutes and was maintained at 3 minutes. Rebound spasm did not occur in LID group, compared with 15.6% of control group (p = 0.001). There were no adverse events in LID group. All serum lidocaine levels were below detectable levels.
Results date posted
2019 Year 06 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2018 Year 10 Month 17 Day
Baseline Characteristics
colonoscopy patients
Participant flow
128 patients were equally allocated into 2 groups.
Adverse events
None
Outcome measures
colon spasm
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 10 Month 01 Day
Date of IRB
2016 Year 07 Month 29 Day
Anticipated trial start date
2016 Year 11 Month 07 Day
Last follow-up date
2017 Year 10 Month 31 Day
Date of closure to data entry
2017 Year 10 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 25 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 07 Day
Last modified on
2019 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027633

Research Plan
Registered date File name
2017/10/10 LIDO study プロトコール_v3.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2017/12/25 LIDO data set -final.pdf


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