UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008227 |
|---|---|
| Receipt number | R000009696 |
| Scientific Title | The Multi-institutional Observational Study of Postoperative QOL in Patients with Rectal Cancer |
| Date of disclosure of the study information | 2012/07/01 |
| Last modified on | 2013/12/24 11:05:16 |
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Basic information
Public title
The Multi-institutional Observational Study of Postoperative QOL in Patients with Rectal Cancer
Acronym
The Multi-institutional Observational Study of Postoperative QOL in Patients with Rectal Cancer
Scientific Title
The Multi-institutional Observational Study of Postoperative QOL in Patients with Rectal Cancer
Scientific Title:Acronym
The Multi-institutional Observational Study of Postoperative QOL in Patients with Rectal Cancer
Region
| Japan |
Condition
Condition
Rectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the postoperative QOL including urinary, rectal and sexual function in patients with rectal cancer
Basic objectives2
Others
Basic objectives -Others
Fact-Finding
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Global QOL Score (Incidence of urinary, rectal and sexual dysfunction)
Key secondary outcomes
Predictor leading to dysfunction
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.Histologically confirmed carcinoma of the rectum.
2.Main occupied lesion of the tumor is rectum or anal canal.
3.Informed consent is obtained.
Key exclusion criteria
1.Urgent operation.
2.Prior resection of rectum.
3.Severe urinary dysfunction requiring catheterization.
4.Those considered inappropriate for participation in this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiharu Sakai, MD |
Organization
Kyoto University Hospital
Division name
Gastro-intestinal Surgery
Zip code
Address
54 Shogoin-kawaharacho, Sakyo-ku, Kyoto, 606-8507, JAPAN
TEL
075-366-7595
ysakai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suguru Hasegawa, MD |
Organization
Kyoto University Hospital
Division name
Gastro-intestinal Surgery
Zip code
Address
Same as above
TEL
075-366-7595
Homepage URL
http://www.kuhp.kyoto-u.ac.jp/~gisurg/class/clinicaltrial_research.html
shase@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Dept. of Gastro-intestinal Surgery, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
京都大学医学附属病院（京都府）
大阪赤十字病院（大阪府）
京都医療センター（京都府）
天理よろづ相談所病院（奈良県）
田附興風会北野病院（京都府）
京都桂病院（京都府）
滋賀県立成人病センター（滋賀県）
西神戸医療センター（兵庫県）
兵庫県立尼崎病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 01 | 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
| 2012 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the postoperative QOL including urinary, rectal and sexual function in patients with rectal cancer
Management information
Registered date
| 2012 | Year | 06 | Month | 21 | Day |
Last modified on
| 2013 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009696
| 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 |
