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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035106
Receipt No. R000039227
Official scientific title of the study Prospective cohort study and construction of a scoring system related to reduced port surgery for colorectal cancers
Date of disclosure of the study information 2018/12/02
Last modified on 2018/12/02

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Basic information
Official scientific title of the study Prospective cohort study and construction of a scoring system related to reduced port surgery for colorectal cancers
Title of the study (Brief title) The efficacy of reduced port surgery for colorectal cancers
Region
Japan

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

Objectives
Narrative objectives1 Efficacy of reduced port surgery (RPS) for colorectal cancers
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To prove the safety of RPS for colorectal cancers
Key secondary outcomes To establish the scoring sytem of difficulty

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
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria colorectal cancer patients
Key exclusion criteria Nil
Target sample size 200

Research contact person
Name of lead principal investigator Umemura Akira
Organization Morioka Municipal Hospital
Division name Department of Surgery
Address 5-15-1 Motomiya, Morioka
TEL 0196350101
Email aumemura@iwate-med.ac.jp

Public contact
Name of contact person Umemura Akira
Organization Morioka Municipal Hospital
Division name Department of Surgery
Address 5-15-1 Motomiya, Morioka
TEL 0196350101
Homepage URL
Email aumemura@iwate-med.ac.jp

Sponsor
Institute Morioka Municipal Hospital
Institute
Department

Funding Source
Organization Morioka Municipal Hospital
Organization
Division
Category of Funding Organization Local Government
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 盛岡市立病院(岩手県)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 02 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 01 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
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 Ongoing

Management information
Registered date
2018 Year 12 Month 02 Day
Last modified on
2018 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039227

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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