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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010781
Receipt No. R000012588
Scientific Title Prospective cohort study of Reduced Port Surgery to colorectal cancer
Date of disclosure of the study information 2013/05/23
Last modified on 2017/11/24

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Basic information
Public title Prospective cohort study of Reduced Port Surgery to colorectal cancer
Acronym Prospective cohort study of Reduced Port Surgery to colorectal cancer
Scientific Title Prospective cohort study of Reduced Port Surgery to colorectal cancer
Scientific Title:Acronym Prospective cohort study of Reduced Port Surgery to colorectal cancer
Region
Japan

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

Objectives
Narrative objectives1 Treatment results are evaluated comparing Reduced Port Surgery to colon cancer with Conventional laparoscopic Surgerry.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain assessment
Key secondary outcomes Rate of Adverse Events
Rate of postoperative mortality
Rate of curative operation
Operation time
Operative blood loss
Cosmetic outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Pathological proven adenocarcinoma.
2)The main site the tumor is occupying is Cecum, Ascending Colon, Sigmoid Colon, Rectosigmoid Colon.
3)Clinical Stage 0-II
4)Possible to be curative resection by lapaloscopic surgery
5)Tumor diameter 2cm or less
6)Aged to 20 to 80 years old
7)No history of gastrointestinal surgery
8)No history of chemotherapy or radiotherapy
9)Performance status(ECOG):0-2
10)Adequate organ functions
11)Written informed consent
Key exclusion criteria 1)Simultaneous or metachronous (within 5 years) double cancers except carcinoma in situ or intramucosal tumor.
2)Psychiatric disease
3)
i)Uncontrolled diabetes mellitus
ii)Continuous systemic steroid or immune suppressant drug
iii)Chronic renal failure which requires hemodialysis
iv)Severe heart disease
v)Severe pulmonary emphysema
4)Continuous analgetic drug treatment
5)Any other cases who are regarded as inadequate for study enrollmet by investigators
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Ito
Organization National Cancer Center Hospital East
Division name Colorectal and Pelvic Surgery
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa City, Chiba, Japan
TEL 04-7133-1111
Email maito@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Ikeda
Organization National Cancer Center Hospital East
Division name Colorectal and Pelvic Surgery
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa City, Chiba, Japan
TEL 04-7133-1111
Homepage URL
Email kojikeda@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 国立がん研究センター東病院(千葉県)、京都大学病院(京都)、藤田保健衛生大学(愛知県)、KKR札幌医療センター斗南病院(北海道)、九州大学病院(福岡県)、大阪大学病院(大阪府)、大阪医科大学病院(大阪府)、静岡県立静岡がんセンター(静岡県)、獨協医科大学越谷病院(埼玉県)、福島県立医科大学病院(福島県)、香川大学病院(香川県)、厚生連長岡中央綜合病院(新潟県)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 23 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 Completed
Date of protocol fixation
2013 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 07 Day
Last follow-up date
2014 Year 11 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective cohort study

Management information
Registered date
2013 Year 05 Month 22 Day
Last modified on
2017 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012588

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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