UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of delayed bleeding after colorectal EMR and polypectomy in patients receiving Rivaroxaban uninterruptedly before retiring
Title of the study (Brief title)	Prospective study of delayed bleeding after colorectal EMR and polypectomy in patients receiving Rivaroxaban uninterruptedly before retiring(RUBR)
Region	Japan

Condition
Condition	colorectal polyps
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	analysis of delayed bleeding after colorectal polypectomy and EMR in patients receiving Rivaroxaban uninterruptedly
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	analysis of delayed bleeding after colorectal polypectomy and EMR for 4 weeks
Key secondary outcomes

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	Medicine Maneuver
Interventions/Control_1	Before the admission of the colorectal polypectomy about 2 weeks,patients start to take a 15mg tablet of Rivaroxaban before retiring. Reducing criteria for 10mg Rivaroxaban Ccr less than50ml/min Age over75 years old Body weight less than50kg Patients admit into the hospital on the day before the polypectomy. The polypectomy is done in the afternoon with uninterruputed using Rivaroxaban before retiring. Patients start to eat after two days from the polypectomy. If bloody stools are not occured,patients are permitted discharge. They take Rivaroxaban before retiring for 4weeks continuously after the polypectomy,and have occurrence of bloody stools observed.
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients receiving anticoagulants with colorectal polyps under 20mm diameter Performance status 0 or 1 WBC over3000/mm3 and under12000/mm3 Hb over9.0g/dL Plt over100000/mm3 AST,ALT under100IU T.Bil under2.0mg/dL Ccr less than1.77mg/dL and Ccr over15ml/min PT-INR under3 (less than70 years old) PT-INR under2.6(over70 years old)
Key exclusion criteria	Contraindicated cases for taking Rivaroxaban Patients with artifical heart valve Patients with vasucular atrial fibrillation Liver chirrhosis patients with type B or C in child-pugh classfication Patients taking azole antifungal drug,the HIV-protease inhihibitors or drugs including cobicistat Patinens contracting acute infective endocarditis Women who are or may be pregnant Patients taking aspirin or Thienopyridine Dialysis patients Patients with past history of gastrointestinal bleeding or intracranial hemorrhage
Target sample size	50

Research contact person
Name of lead principal investigator	manabu kubota
Organization	Asahi General Hospital
Division name	Dept. of Gastroenterology
Address	I-1326 Asahi-shi Chiba-ken JAPAN
TEL	0479-63-8111
Email	manabukuboa@hospital.asahi.chiba.jp

Public contact
Name of contact person	manabu kubota
Organization	Asahi General Hospital
Division name	Dept. of Gastroenterology
Address	I-1326 Asahi-shi Chiba-ken JAPAN
TEL	0479-63-8111
Homepage URL
Email	manabukuboa@hospital.asahi.chiba.jp

Sponsor
Institute	Asahi General Hospital
Institute
Department

Funding Source
Organization	Asahi General Hospital
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

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 31 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 04 Month 06 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 30 Day
Last modified on	2016 Year 11 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025879