UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024733 |
|---|---|
| Receipt number | 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 16:41:05 |
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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
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
togashik@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
