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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010764
Receipt No. R000012584
Scientific Title Prospective study of urinary and sexual dysfunction after surgery for rectal cancer
Date of disclosure of the study information 2013/05/20
Last modified on 2017/11/24

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Basic information
Public title Prospective study of urinary and sexual dysfunction after surgery for rectal cancer
Acronym Prospective study of urinary and sexual dysfunction after surgery for rectal cancer
Scientific Title Prospective study of urinary and sexual dysfunction after surgery for rectal cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Masaaki Ito
Organization National Cancer Center Hospital East
Division name Colorectal Surgery
Zip code
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
1st name
Middle name
Last name Masaaki Ito
Organization National Cancer Center Hospital East
Division name Colorectal Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
2012 Year 10 Month 22 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000012584

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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