UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The cleansing ability of novel microfiber cloth on laparoscope
Title of the study (Brief title)	The cleansing ability of novel microfiber cloth on laparoscope
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective is to assess the cleansing ability of novel microfiber cloth on laparoscope
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The frequency and time to intraoperatively wipe laparoscope
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	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	wiping laparoscopy by microfiber cleansing cloth
Interventions/Control_2	wiping laparoscopy by conventional gauze
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Colorectal cancer patients who will undergo laparoscopic surgery
Key exclusion criteria	Colorectal cancer patients who will undergo open surgery
Target sample size	40

Research contact person
Name of lead principal investigator	Hirotoshi Hasegawa
Organization	Department of surgery, School of Medicine, Keio university
Division name	general and gastrointestinal surgery
Address	35, Shinanomachi, Shinjyuku-ku, Tokyo
TEL	03-3353-1211
Email	hasegawa@z8.keio.jp

Public contact
Name of contact person	Koji Okabayashi
Organization	Department of surgery, School of Medicine, Keio university
Division name	general and gastrointestinal surgery
Address	35, Shinanomachi, Shinjyuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	ken.d05sm098@gmail.com

Sponsor
Institute	Department of surgery, School of Medicine, Keio university
Institute
Department

Funding Source
Organization	Department of surgery, School of Medicine, Keio university
Organization
Division
Category of Funding Organization	Other
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 11 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 10 Month 02 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date	2016 Year 07 Month 31 Day
Date of closure to data entry	2016 Year 07 Month 31 Day
Date trial data considered complete	2016 Year 07 Month 31 Day
Date analysis concluded

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

Management information
Registered date	2015 Year 10 Month 15 Day
Last modified on	2017 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022292