UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of urinary and sexual dysfunction after surgery for rectal cancer
Title of the study (Brief title)	Prospective study of urinary and sexual dysfunction after surgery for rectal cancer
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to prospective research frequency of urinary and sexual dysfunction after surgery for rectal cancer using international index and to evaluate the difference of function by the resection range and whether laparoscope is used.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Urinary and sexual dysfunction
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	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Primary colorectal cancer operation 2.Histologically confirmed adenocarcinoma of the Colorectal 3.Site of tumor is Ra or Rb or RS 4.c-stage 0-III(TNM7th)without T4b 5.Possible to be curative resection 6.Aged 20 to 70 years old 7.PS(ECOG) of 0 or 1 8.No history of intestines resection 9.No prior chemotherapy or radiation therapy. Without preoperative chemotherapy and radiation therapy for rectal cancer. 10.No prior Urinary and sex organs 11.No treatment of ED 12.Written informed consent
Key exclusion criteria	1.Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma. 2.Uncontrollable diabetes mellitus or routine administration of insulin. 3.Cardiac disease or congestive heart failure that would take medication in order to prevent lethal ventricular arrhythmias. 4.Severe mental disease 5.Doctor' s decision for exclusion
Target sample size	500

Research contact person
Name of lead principal investigator	Masaaki Ito
Organization	National Cancer Center Hospital East
Division name	Colorectal Surgery
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
TEL	04-7133-1111
Email	maito@east.ncc.go.jp

Public contact
Name of contact person	Masaaki Ito
Organization	National Cancer Center Hospital East
Division name	Colorectal Surgery
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
TEL	04-7133-1111
Homepage URL
Email	maito@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	National Cancer Center Hospital East
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	2013 Year 05 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 22 Day
Anticipated trial start date	2012 Year 11 Month 20 Day
Last follow-up date	2014 Year 11 Month 01 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	We will examine that the relationship of an autonomic nerve damage degree and urinary and sexual dysfunction after surgery by prospective study

Management information
Registered date	2013 Year 05 Month 20 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=R000012584