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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009722
Receipt No. R000011397
Scientific Title Evaluation of efficiency of polarized laparoscope in laparoscopic colorectal cancer surgery
Date of disclosure of the study information 2013/02/13
Last modified on 2015/01/07

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Basic information
Public title Evaluation of efficiency of polarized laparoscope in laparoscopic colorectal cancer surgery
Acronym Evaluation of efficiency of polarized laparoscope in laparoscopic colorectal cancer surgery
Scientific Title Evaluation of efficiency of polarized laparoscope in laparoscopic colorectal cancer surgery
Scientific Title:Acronym Evaluation of efficiency of polarized laparoscope in laparoscopic colorectal cancer surgery
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficiency of polarizing laparoscope in colorectal cancer surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes visibility of anatomic structures during operation
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
Device,equipment
Interventions/Control_1 polarizing laparoscope
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

Not applicable
Gender Male and Female
Key inclusion criteria eligible for laparoscopic colorectal cancer surgery
written informed consent
Key exclusion criteria patents who are suffering severe circulatory or respiratory problem
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiharu Sakai
Organization Kyoto University Hospital
Division name Dept. of Surgery
Zip code
Address Shoginkawaharacho, Sakyo, Kyoto, JAPAN
TEL 075-366-7595
Email shase@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Suguru Hasegawa
Organization Kyoto University Hospital
Division name Dept. of Surgery
Zip code
Address Shoginkawaharacho, Sakyo, Kyoto, JAPAN
TEL 075-366-7595
Homepage URL
Email shase@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Surgery, Kyoto University Hospital
Institute
Department

Funding Source
Organization Department of Surgery, Kyoto University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 京都大学病院

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 13 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 Terminated
Date of protocol fixation
2013 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 07 Day
Last modified on
2015 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011397

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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