UMIN-CTR Clinical Trial

Basic information
Public title	Prospective cohort study and construction of a scoring system related to reduced port surgery for colorectal cancers
Acronym	The efficacy of reduced port surgery for colorectal cancers
Scientific Title	Prospective cohort study and construction of a scoring system related to reduced port surgery for colorectal cancers
Scientific Title:Acronym	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	1st name Akira Middle name Last name Umemura
Organization	Morioka Municipal Hospital
Division name	Department of Surgery
Zip code	020-0866
Address	5-15-1 Motomiya, Morioka
TEL	0196350101
Email	aumemura@iwate-med.ac.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Umemura
Organization	Morioka Municipal Hospital
Division name	Department of Surgery
Zip code	020-0866
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)

IRB Contact (For public release)
Organization	Morioka Municipal Hospital
Address	5-15-1 Motomoiya, Morioka city
Tel	0196350101
Email	auau001@hotmail.com

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

Related information
URL releasing protocol	https://www.sciencedirect.com/science/article/pii/S1015958421003110
Publication of results	Published

Result
URL related to results and publications	https://www.sciencedirect.com/science/article/pii/S1015958421003110
Number of participants that the trial has enrolled	112
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	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 12 Month 31 Day
Date analysis concluded	2021 Year 01 Month 31 Day

Other
Other related information	Paper accepted

Management information
Registered date	2018 Year 12 Month 02 Day
Last modified on	2021 Year 06 Month 26 Day

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