UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038133 |
|---|---|
| Receipt number | R000043211 |
| Scientific Title | A randomized controlled trial to determine whether Video improves preoperative counseling for rectal cancer surgery |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2023/03/20 18:23:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A randomized controlled trial to determine whether Video improves preoperative counseling for rectal cancer surgery
Acronym
A randomized controlled trial to determine whether Video improves preoperative counseling for rectal cancer surgery
Scientific Title
A randomized controlled trial to determine whether Video improves preoperative counseling for rectal cancer surgery
Scientific Title:Acronym
A randomized controlled trial to determine whether Video improves preoperative counseling for rectal cancer surgery
Region
| Japan |
Condition
Condition
rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the value of Video in preoperative counseling for rectal cancer surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
patient's comprehension, satisfaction, and anxiety after preoperative counseling
Key secondary outcomes
time required for preoperative counseling
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
using the 15-minute video when preoperative counseling
Interventions/Control_2
giving the conventional explanation when preoperative counseling
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
rectal cancer patients scheduled for surgery
Key exclusion criteria
when consent cannnot be obtained due to dementia, etc
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Kinugasa |
Organization
Tokyo Medical and Dental University
Division name
Department of Gastrointestinal Surgery
Zip code
1138519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358035254
kinugasa.srg1@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Kasai |
Organization
Tokyo Medical and Dental University
Division name
Department of Gastrointestinal Surgery
Zip code
1138519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358035254
Homepage URL
skasai.srg1@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
0338136111
info.bec@tmd.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
東京医科歯科大学医学部付属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/ases.13147
Number of participants that the trial has enrolled
34
Results
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
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 27 | Day |
Last modified on
| 2023 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043211
