UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Quality of life after rectal cancer surgery
Title of the study (Brief title)	QOL-RC
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the quolity of life after rectal cancer surgery
Basic objectives2	Others
Basic objectives -Others	observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate the change of quolitay of life( anal and urogenital function) after ractal cancer surgery
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Primary rectal cancer Any approach eligible ECOG-PS0-2 Written IC
Key exclusion criteria	Emergency surgery History of rectal cancer surgery severe urinary disfunction
Target sample size	100

Research contact person
Name of lead principal investigator	Suguru Hasegawa
Organization	Fukuoka University Hospital
Division name	Gastroenterological surgery
Address	Nanakuma 7-45-1 Jonan-ku, Fukuoka, Japan
TEL	81-92-801-1011
Email	shase@fukuoka-u.ac.jp

Public contact
Name of contact person	Naoya Aisu
Organization	Fukuoka University Hospital
Division name	Gastroenterological surgery
Address	Nanakuma 7-45-1 Jonan-ku, Fukuoka, Japan
TEL	81-92-801-1011
Homepage URL
Email	ice13man1978@yahoo.co.jp

Sponsor
Institute	Fukuoka University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
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	福岡大学病院

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 15 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 06 Month 13 Day
Anticipated trial start date	2016 Year 06 Month 14 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	preinitiation

Management information
Registered date	2016 Year 06 Month 15 Day
Last modified on	2016 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026207