UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032834 |
|---|---|
| Receipt number | R000037443 |
| Scientific Title | Evaluation of long term quality of life after aboral pouch compared with roux-en-Y reconstruction after total gastrectomy for gastric cancer |
| Date of disclosure of the study information | 2018/06/10 |
| Last modified on | 2018/06/01 15:56:18 |
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Basic information
Public title
Evaluation of long term quality of life after aboral pouch compared with roux-en-Y reconstruction after total gastrectomy for gastric cancer
Acronym
Evaluation of long term quality of life after aboral pouch compared with roux-en-Y reconstruction after total gastrectomy
Scientific Title
Evaluation of long term quality of life after aboral pouch compared with roux-en-Y reconstruction after total gastrectomy for gastric cancer
Scientific Title:Acronym
Evaluation of long term quality of life after aboral pouch compared with roux-en-Y reconstruction after total gastrectomy
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of long term quality of life after aboral pouch reconstruction compared with Roux-en-Y reconstruction after total gastrectomy for gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of quality of life of aboral pouch reconstruction after total gastrectomy to that of the Roux-en-Y reconstruction
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. Understanding the content of the questionnaire
2. Consent for this trial
3. Resister for CCOG 1101 trial
Key exclusion criteria
No consent for this trial
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Kodera |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2250
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chie Tanaka |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2250
Homepage URL
chtanaka@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
| 2018 | Year | 06 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation study
Management information
Registered date
| 2018 | Year | 06 | Month | 01 | Day |
Last modified on
| 2018 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037443
