UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational study for frailty in older patients of colorectal cancer surgery.
Title of the study (Brief title)	Observational study for frailty in colorectal cancer surgery.
Region	Japan

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

Objectives
Narrative objectives1	To investigate the association of frailty with perioperative morbidity and mortality in colorectal cancer patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of the impact of frailty in colorectal cancer surgery.
Key secondary 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	65 years-old <=
Age-upper limit	110 years-old >
Gender	Male and Female
Key inclusion criteria	We include patients of 65 years and older, who undergo colorectal cancer surgery.
Key exclusion criteria	We exclude patients who are treated as ineligible.
Target sample size	500

Research contact person
Name of lead principal investigator	Kenji Matsuda
Organization	Wakayama Medical University, School of Medicine
Division name	Second Department of Surgery
Address	811-1, Kimiidera, Wakayama city, Wakayama, Japan
TEL	073-441-0613
Email	kmatsuda@wakayama-med.ac.jp

Public contact
Name of contact person	Kenji Matsuda
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1, Kimiidera, Wakayama city, Wakayama, Japan
TEL	073-441-0613
Homepage URL
Email	kmatsuda@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University, School of Medicine
Institute
Department

Funding Source
Organization	Wakayama Medical University, School of Medicine
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 24 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 03 Month 06 Day
Anticipated trial start date	2017 Year 03 Month 06 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	None

Management information
Registered date	2017 Year 03 Month 24 Day
Last modified on	2017 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030640