UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective cohort study of Reduced Port Surgery to colorectal cancer
Title of the study (Brief title)	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	Masaaki Ito
Organization	National Cancer Center Hospital East
Division name	Colorectal and Pelvic Surgery
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	Koji Ikeda
Organization	National Cancer Center Hospital East
Division name	Colorectal and Pelvic Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000012588