UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective exploratory study on the evaluation of post-polypectomy sites after conventional and cold polypectomy for rectal polyps
Title of the study (Brief title)	the endoscopic evaluation after conventional and cold polypectomy
Region	Japan

Condition
Condition	rectal and rectosigmoid polyps
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the post-polypectomy site after conventional and cold polypectomy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	The endoscopic evaluation of post-polypectomy site (size of ulcer, presence of blood, presence of residual tumor)
Key secondary outcomes	The resection depth The incidence of immediate bleeding The incidence of delayed bleeding The incidence of delayed perforation The pathological evaluation of complete resection

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	conventional snare polypectomy
Interventions/Control_2	cold snare polypectomy
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	1) 20 years old and older 2) Patients with rectal or rectosigmoid polyps less than 10 mm in diameter 3) Written informed consent
Key exclusion criteria	1) Polyps suspected of being cancers 2) Patients with diseases that cause the bleeding tendency 3) Patients who have serious complications 4) Pregnant 5) Others
Target sample size	50

Research contact person
Name of lead principal investigator	Sho Suzuki
Organization	Yuri-Kumiai General Hospital
Division name	Department of Gastroenterology
Address	38, Kawaguchiazayago, Yurihonjoshi, Akita, Japan
TEL	0184-27-1200
Email	s.sho.salubriter.mail@gmail.com

Public contact
Name of contact person	Sho Suzuki
Organization	Yuri-Kumiai General Hospital
Division name	Department of Gastroenterology
Address	38, Kawaguchiazayago, Yurihonjoshi, Akita, Japan
TEL	0184-27-1200
Homepage URL
Email	s.sho.salubriter.mail@gmail.com

Sponsor
Institute	Yuri-Kumiai General Hospital
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)

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	2015 Year 07 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 09 Day
Anticipated trial start date	2015 Year 07 Month 14 Day
Last follow-up date	2017 Year 04 Month 30 Day
Date of closure to data entry	2017 Year 04 Month 30 Day
Date trial data considered complete	2017 Year 04 Month 30 Day
Date analysis concluded	2017 Year 05 Month 30 Day

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

Management information
Registered date	2015 Year 07 Month 13 Day
Last modified on	2018 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021158