UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022751 |
|---|---|
| Receipt number | R000026207 |
| Scientific Title | Quality of life after rectal cancer surgery |
| Date of disclosure of the study information | 2016/06/15 |
| Last modified on | 2016/06/15 12:54:09 |
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Basic information
Public title
Quality of life after rectal cancer surgery
Acronym
QOL-RC
Scientific Title
Quality of life after rectal cancer surgery
Scientific Title:Acronym
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
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
| 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
| 1st name | |
| Middle name | |
| Last name | Suguru Hasegawa |
Organization
Fukuoka University Hospital
Division name
Gastroenterological surgery
Zip code
Address
Nanakuma 7-45-1 Jonan-ku, Fukuoka, Japan
TEL
81-92-801-1011
shase@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoya Aisu |
Organization
Fukuoka University Hospital
Division name
Gastroenterological surgery
Zip code
Address
Nanakuma 7-45-1 Jonan-ku, Fukuoka, Japan
TEL
81-92-801-1011
Homepage URL
ice13man1978@yahoo.co.jp
Sponsor or person
Institute
Fukuoka University Hospital
Institute
Department
Personal name
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)
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
福岡大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 06 | Month | 13 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026207
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
