UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018856 |
|---|---|
| Receipt number | R000021810 |
| Scientific Title | Evaluation of long term quality of life after aboral pouch reconstruction compared with Roux-en-Y reconstruction after total gastrectomy for gastric cancer |
| Date of disclosure of the study information | 2015/08/30 |
| Last modified on | 2018/09/01 09:40:37 |
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Basic information
Public title
Evaluation of long term quality of life after aboral pouch reconstruction compared with Roux-en-Y reconstruction after total gastrectomy for gastric cancer
Acronym
Evaluation of long term quality of life after aboral pouch reconstruction compared with Roux-en-Y reconstruction after total gastrectomy
Scientific Title
Evaluation of long term quality of life after aboral pouch reconstruction 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 reconstruction 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
To compare postoperative quality of life between aboral pouch reconstruction and Roux-en-Y reconstruction after total gastrectomy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare postoperative quality of life between aboral pouch reconstruction and Roux-en-Y reconstruction after total gastrectomy.
Key secondary outcomes
Scores of questionnaires;QLQ-C30, STO22 and PGSAS37, body composition, blood test, disease-free survival and overall survival.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A: Roux-en-Y reconstruction
Interventions/Control_2
B: Aboral pouch reconstruction
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) Provided written informed consent
2) Patients who were enrolled in CCOG1101 study (Evaluation of Aboral Pouch Reconstruction After Total Gastrectomy in Patients with Gastric Cancer : A Prospective Randomized Controlled Trial)
Key exclusion criteria
1) Considered inadequate for inclusion in this trial by the physician
2) Patients without consent for enrollment
Target sample size
100
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 (Surgery II)
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
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 (Surgery II)
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2250
Homepage URL
chtanaka@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine
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 | 08 | Month | 30 | 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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | 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
Management information
Registered date
| 2015 | Year | 08 | Month | 30 | Day |
Last modified on
| 2018 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021810
