UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016781 |
|---|---|
| Receipt number | R000019100 |
| Scientific Title | The analysis of risk facotors of post colon ESD pain |
| Date of disclosure of the study information | 2015/03/11 |
| Last modified on | 2019/12/06 21:07:28 |
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Basic information
Public title
The analysis of risk facotors of post colon ESD pain
Acronym
The analysis of risk facotors of post colon ESD pain
Scientific Title
The analysis of risk facotors of post colon ESD pain
Scientific Title:Acronym
The analysis of risk facotors of post colon ESD pain
Region
| Japan |
Condition
Condition
The adapted lesion of colon ESD
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the risk factor of post colon ESD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain scale (Visula analog scale) (POD1, POD2, POD3 and POD4)
Key secondary outcomes
Size of the lesion
Location of the lesion
Time of procedure
Use of analgetic agent
Use of antiboitics
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with ESD adapted colonic lesions
Key exclusion criteria
History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure
Histroy of regular use of analgesic
Pregnancy or possibility of pregnancy
Patients judged as being inappropriate candidates for the trial by the investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Higurashi |
Organization
Yokohama City University
Division name
Department of endoscopy
Zip code
236-0004
Address
3-9 Fukuura Kanazawa Yokohama Japan
TEL
045-787-2640
takuma_h@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Higurashi |
Organization
Yokohama City University
Division name
Department of endoscopy
Zip code
236-0004
Address
3-9 Fukuura Kanazawa Yokohama Japan
TEL
045-787-2640
Homepage URL
takuma_h@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Omori Red Cross Hospital
NTT Medical Center Tokyo
Hiratsuka City Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Hospital IRB
Address
3-9 Fukuura Kanazawa-ku Yokohama City
Tel
045-787-2640
irb@yokohama-cu.ac.jp
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
横浜市立大学 大森赤十字病院 NTT関東病院 平塚市民病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 11 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5842075/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5842075/
Number of participants that the trial has enrolled
106
Results
Female gender, location of lesion in the cecum, and ESD operation time >？90 minutes were significant risk factors independent of PECS. These findings are important to management of PECS.？
Results date posted
| 2019 | Year | 12 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2017 | Year | 03 | Month | 07 | Day |
Baseline Characteristics
This was a prospective multicenter observational trial (UMIN000016781) conducted in 106 of 223 patients who underwent ESD between March 2015 and April 2016. We investigated age, sex, tumor location, ESD operation time, lesion size, duration of hospitalization, and frequency of PECS.？We defined PECS as local abdominal pain (evaluated on a visual analogue scale) in the region corresponding to the site of the ESD that occurred within 4 days of the procedure.
Participant flow
This was a prospective multicenter observational trial (UMIN000016781) conducted in 106 of 223 patients who underwent ESD between March 2015 and April 2016. We investigated age, sex, tumor location, ESD operation time, lesion size, duration of hospitalization, and frequency of PECS.？We defined PECS as local abdominal pain (evaluated on a visual analogue scale) in the region corresponding to the site of the ESD that occurred within 4 days of the procedure.
Adverse events
PECS occurred in 15/106 (14.2？%), and 10 were women ( P ？=？0.01, OR: 7.74 [1.6？-？36.4]), 7 had lesions in the cecum ( P ？<？0.001, OR: 20.6 [3.7？-？115.2]), and 9 in whom ESD operation time was >？90？min ( P ？=？0.002, OR: 10.3 [2.4？-？44.6]). Frequency of deviation from the prescribed clinical path was significantly higher (47？% [7/15] vs. 2？% [2/91], P ？<？0.001, OR: 38.9 [6.9？-？219.6]), and hospital stay was significantly longer in the PECS group.
Outcome measures
PECS occurred in 15/106 (14.2？%), and 10 were women ( P ？=？0.01, OR: 7.74 [1.6？-？36.4]), 7 had lesions in the cecum ( P ？<？0.001, OR: 20.6 [3.7？-？115.2]), and 9 in whom ESD operation time was >？90？min ( P ？=？0.002, OR: 10.3 [2.4？-？44.6]). Frequency of deviation from the prescribed clinical path was significantly higher (47？% [7/15] vs. 2？% [2/91], P ？<？0.001, OR: 38.9 [6.9？-？219.6]), and hospital stay was significantly longer in the PECS group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
Prospective observational Study
Management information
Registered date
| 2015 | Year | 03 | Month | 11 | Day |
Last modified on
| 2019 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019100
