UMIN-CTR Clinical Trial

Basic information
Public title	A study evaluating the safety of early closure of diverting ileostomy after low anterior resection
Acronym	Eraly closure of eleostomy after LAR
Scientific Title	A study evaluating the safety of early closure of diverting ileostomy after low anterior resection
Scientific Title:Acronym	Eraly closure of eleostomy after LAR
Region	Japan

Condition
Condition	Rectum
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluating the safety of early closure of diverting ileostomy after low anterior resection
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of anastomotic leakage after early closure
Key secondary outcomes	tha rate of early closure rate of surgical site infection rate of complications detection of leakage before stoma closure medical cost

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	early closure of diverting ileostomy
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Ra or Rb rectal cancer proved by endoscopy or pathological examination. Low anterior resection and creation of covering ileostomy is planned. Rectal cancer without metastasis is diagnosed. Patients are age at 20 or more than 20. Informed consents are obtained. No severe dysfunction in vital organs is pointed out.
Key exclusion criteria	When the investigator considers recruitment of the patients is inappropriate (ie. severe organ dysfunction). When informed consent is not obtained.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hanazaki Middle name Last name Kazuhiro
Organization	Kochi Medical Shool
Division name	Surgery
Zip code	783-8505
Address	Oko-cho, Kohasu, Nankoku, Kochi
TEL	088-880-2370
Email	hanazaki@kochi-u.ac.jp

Public contact
Name of contact person	1st name Maeda Middle name Last name Hiromichi
Organization	Kochi Medical Shool Hospital
Division name	Surgery
Zip code	783-8505
Address	Oko-cho, Kohasu, Nankoku, Kochi
TEL	088-880-2370
Homepage URL
Email	hmaeda@kochi-u.ac.jp

Sponsor
Institute	Kochi Medical School
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kochi Medical School
Address	Oko-cho, Kohasu, Nankoku, Kochi
Tel	088-880-2226
Email	rinri21@kochi-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	2019 Year 04 Month 03 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	13
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 04 Month 02 Day
Date of IRB	2019 Year 04 Month 02 Day
Anticipated trial start date	2019 Year 04 Month 02 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry	2021 Year 07 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 04 Month 02 Day
Last modified on	2022 Year 05 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041026