UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048314 |
|---|---|
| Receipt number | R000055059 |
| Scientific Title | Impacts of trans-anal tube placement in patients with sigmoid colon cancer: Risk verification analysis using inverse probability weighting analysis |
| Date of disclosure of the study information | 2022/07/15 |
| Last modified on | 2022/07/07 16:38:08 |
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Basic information
Public title
Impacts of trans-anal tube placement in patients with sigmoid colon cancer
Acronym
Impacts of TDT in patients with sigmoid colon cancer
Scientific Title
Impacts of trans-anal tube placement in patients with sigmoid colon cancer: Risk verification analysis using inverse probability weighting analysis
Scientific Title:Acronym
Impact of TDT following sigmoidectomy
Region
| Japan |
Condition
Condition
Sigmoid colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the factors affecting the association between TDT placement and anastomotic leakage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the presence or absence of anastomotic leakage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Trans anal tube placement
Interventions/Control_2
non trans anal tube placement
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
The sigmoid colon cancer patients who underwent sigmoidectomy
Key exclusion criteria
emergency surgery
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Tetsuro |
| Middle name | |
| Last name | Tominaga |
Organization
Nagasaki University Graduate School of Biological Sciences
Division name
Surgical oncology
Zip code
8528156
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL
0958197304
tetsuro.tominaga@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuro |
| Middle name | |
| Last name | Tominaga |
Organization
Nagasaki University Graduate School of Biological Sciences
Division name
Surgical oncology
Zip code
8528156
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL
0958197304
Homepage URL
tetsuro.tominaga@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biological Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Graduate School of Biological Sciences
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
Clinical Research Review Boards of Nagasaki university hospitals
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
0958197256
ssato@nagasaki-u.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Preinitiation
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 07 | Day |
Last modified on
| 2022 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055059
