UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008227
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email shase@kuhp.kyoto-u.ac.jp

Sponsor
Institute Dept. of Gastro-intestinal Surgery, Kyoto University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009696

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.