UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010764 |
|---|---|
| Receipt number | 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 14:25:46 |
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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
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
maito@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012584
