UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of the new strategy by enhanced abdominal CT for the patients with diverticula and hematochezia.
Acronym	The efficacy of the new strategy for the patients with diverticula and hematochezia.
Scientific Title	The efficacy of the new strategy by enhanced abdominal CT for the patients with diverticula and hematochezia.
Scientific Title:Acronym	The efficacy of the new strategy for the patients with diverticula and hematochezia.
Region	Japan

Condition
Condition	colonic diverticula
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Multicenter prospective study of the efficacy of the treatment strategy for the patients with colonic diverticula and hematochezia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of re-bleeding in the hospital
Key secondary outcomes

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	Treatment
Type of intervention	Other
Interventions/Control_1	the group of urgent colonoscopy. If bleeding point is detected, endoscopic hemostasis is performed. There is no re-bleeding, from day 2 to day 4 ingestion is started. After day 5 the patient discharges hospital.
Interventions/Control_2	the group of conservative treatment. Without urgent colonoscopy, the patient is treated by intravenous hemostatic agent. There is no re-bleeding, from day 2 to day 4 ingestion is started. After day 5 the patient discharges hospital.
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients with colonic diverticula by abdominal enhanced CT or colonoscopy, without extravazation. The patients with hematochezia. The patients who agreed to this study.
Key exclusion criteria	The patients with extravasation in abdominal enhanced CT. The patients who were suspected the other disease, for example ischemic colitis and colorectal cancer
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masahide Middle name Last name Ebi
Organization	Aichi medical university
Division name	Department of Gastroentelorogy
Zip code	4801195
Address	1-1 yazako-karimata Nagakute-city Aichi prefecture
TEL	0561-62-3311
Email	mebi@aichi-med-u.ac.jp

Public contact
Name of contact person	1st name Masahide Middle name Last name Ebi
Organization	Aichi medical university
Division name	Department of Gastroentelorogy
Zip code	4801195
Address	1-1 yazako-karimata Nagakute-city Aichi prefecture Japan
TEL	0561-62-3311
Homepage URL
Email	mebi@aichi-med-u.ac.jp

Sponsor
Institute	Aichi medical university
Institute
Department

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

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

IRB Contact (For public release)
Organization	Aichi medical university
Address	1-1 Yazakokarimata, Nagakute
Tel	0561623311
Email	mebi@aichi-med-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	2016 Year 05 Month 09 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results	Unpublished

Result
URL related to results and publications	https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled	30
Results	finished
Results date posted	2021 Year 05 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	bloody stool
Participant flow	informed consent
Adverse events	none
Outcome measures	the usefulness of strategy
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 05 Month 02 Day
Date of IRB	2016 Year 05 Month 09 Day
Anticipated trial start date	2016 Year 05 Month 09 Day
Last follow-up date	2019 Year 03 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	2016 Year 05 Month 02 Day
Last modified on	2021 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025399