UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017265 |
|---|---|
| Receipt number | R000020034 |
| Scientific Title | Quality of life after rectal cancer surgery |
| Date of disclosure of the study information | 2015/05/10 |
| Last modified on | 2019/07/03 13:53:02 |
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Basic information
Public title
Quality of life after rectal cancer surgery
Acronym
RC-QOL-II
Scientific Title
Quality of life after rectal cancer surgery
Scientific Title:Acronym
RC-QOL-II
Region
| Japan |
Condition
Condition
rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the QOL 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 QOL, anal and urogenital function after rectal 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
1) Primary rectal cancer patients who are candidate for surgery
2) Any approach eligible (open, lap, robo, transanal)
3) Age >=20, <=80
4) ECOG-PS0-2
5) Written IC
Key exclusion criteria
1) Emergent surgery
2) History of rectal surgery
3) Severe urinary disfunction
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiharu Sakai |
Organization
Kyoto University Hospital
Division name
Surgery
Zip code
Address
Shogoinkawaharacho 54, Sakyo, Kyoto, Japan
TEL
81-75-366-7595
ysakai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koya Hida |
Organization
Kyoto University Hospital
Division name
Surgery
Zip code
Address
Shogoinkawaharacho 54, Sakyo, Kyoto, Japan
TEL
81-75-366-7595
Homepage URL
hidakoya@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto Unversity
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 10 | 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
| 2015 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | 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
| 2015 | Year | 04 | Month | 24 | Day |
Last modified on
| 2019 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020034
