UMIN-CTR Clinical Trial

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
Email	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
Email	tetsuro.tominaga@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Graduate School of Biological Sciences
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055059