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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012352
Receipt No. 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

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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
Email 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
Email togashik@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

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
Email

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
URL(English) https://upload.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


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