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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032834
Receipt No. R000037443
Official scientific title of the study 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

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Basic information
Official scientific title of the study Evaluation of long term quality of life after aboral pouch compared with roux-en-Y reconstruction after total gastrectomy for gastric cancer
Title of the study (Brief title) 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 Yasuhiro Kodera
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2250
Email ykodera@med.nagoya-u.ac.jp

Public contact
Name of contact person Chie Tanaka
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2250
Homepage URL
Email chtanaka@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

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)

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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 07 Month 24 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037443

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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