UMIN-CTR Clinical Trial

Basic information
Public title	The randomized study to evaluate whether the instruments for clearing laparoscope reduce the surgical stress in colorectal cancer surgery.
Acronym	The Randomized control study that the instruments for clearing laparoscope affect to the surgical stress.
Scientific Title	The randomized study to evaluate whether the instruments for clearing laparoscope reduce the multifaceted surgical stress in colorectal cancer surgery.
Scientific Title:Acronym	The Randomized control study that the instruments for clearing laparoscope affect to the multifaced surgical stress.
Region	Japan

Condition
Condition	Colorectal Cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether instruments for clearing lens of laparoscope reduce the multifaceted surgical stress in the colorectal operation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate whether instruments for clearing lens of laparoscope reduce the multifaceted surgical stress in the colorectal operation.
Key secondary outcomes	The duration of operation and the number of clearing lens of laparoscope

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 considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	Clearing lens of laparoscope using the warm saline and gaze
Interventions/Control_2	Clearing lens of laparoscope using the instrument for clearing lens of laparoscope (OpClear)
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	Incursion criteria for a patient (1)diagnosed colorectal cancer (2)the patients are planned laparoscopic surgery for colorectal cancer. (3) the patients totally understand this research (4)the patients with accepting consent to participate in this study Incursion criteria for a doctor (1)Physician who can perform laparoscopic colectomy and the main operator of laparoscopic colectomy for colorectal cancer.
Key exclusion criteria	exclusion criteria for patients (1)Patients who aren't able to totally understand this study (2)the patients are planned the lateral lymph node dissection (3)BMI>35 (4)Patients who are pregnant, may be pregnant, or wish to be pregnant during treatment. (5) the patients are participated in another clinical trials at the same time or within 30 days before participation in this trial. (6) The patients who are judged to be inappropriate for this study by a doctor. exclusion criteria for a doctor (1) The Surgeons have had less than 5 cases of laparoscopic colorectal resection.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Watanabe
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Zip code	2320024
Address	4-57 Urafunecho, Minaki-ku, Yokohama
TEL	045-261-5656
Email	nabe-jun@comet.ocn.ne.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Miyamoto
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Zip code	2320024
Address	4-57 Urafunecho, Minaki-ku, Yokohama
TEL	045-261-5656
Homepage URL
Email	yo-chan.634@nifty.com

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	AMUKO
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Yokohama City University Hospital and Yokoasuka Kyosai Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama NEXT
Address	1-1-1 Fukuura, Kanazawa-ku, Yokohama
Tel	045-370-7949
Email	ynextedu@yokohama-cu.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	横浜市立大学附属市民総合医療センター（神奈川県）、横浜市立大学附属病院（神奈川県）、横須賀共済病院　（神奈川県）

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 01 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
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	Preinitiation
Date of protocol fixation	2019 Year 11 Month 06 Day
Date of IRB	2019 Year 11 Month 13 Day
Anticipated trial start date	2019 Year 12 Month 01 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 11 Month 25 Day
Last modified on	2019 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044070

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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