UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012352 |
|---|---|
| Receipt number | R000014443 |
| Scientific Title | Inhibitory Effect of Lidocaine on Colonic Spasms during Colonoscopy |
| Date of disclosure of the study information | 2013/11/25 |
| Last modified on | 2017/11/17 21:48:28 |
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Basic information
Public title
Inhibitory Effect of Lidocaine on Colonic Spasms during Colonoscopy
Acronym
Lidocaine Study
Scientific Title
Inhibitory Effect of Lidocaine on Colonic Spasms during Colonoscopy
Scientific Title:Acronym
Lidocaine Study
Region
| Japan |
Condition
Condition
colorectal disease
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify inhibitory effect of lidocaine on colonic spasms during colonoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
lasting time of colonic spasm
Key secondary outcomes
number of colonic spasm, patient tolerance, occurrence of complication, occurrence of rebound phenomenon, impression of colonoscopist
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Lidocaine spray
Interventions/Control_2
Peppermint spray
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
| 35 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have colonic lesions for meticulous observation
Key exclusion criteria
Lidocaine allergy
Inflammatory bowel disease including ulcerative colitis, Crhon disease and etc.
Target sample size
60
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
0242-27-2100
togashik@fmu.ac.jp
Public contact
Name of contact person
| 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
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 Medical 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
1805
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）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.thieme-connect.com/DOI/DOI?10.1055/s-0043-105489
Number of participants that the trial has enrolled
Results
There are no significant differences in patient demographics. Spasm was inhibited in almost all patients in both groups, with a similar median duration (lidocaine 227sec vs. peppermint 212.5sec, p=0.508). In contrast, rebound spasm occurred less frequently in the lidocaine group (lidocaine 7% vs. peppermint 47%, p=0.001). There were no adverse events or symptoms associated with administration of the solutions.
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
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 11 | Month | 10 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
The data have been published in "Endoscopy International Open".
Management information
Registered date
| 2013 | Year | 11 | Month | 19 | Day |
Last modified on
| 2017 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014443
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/05/23 | 01 研究計画書（別紙様式１）Lid20140910修正.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
