UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021990 |
|---|---|
| Receipt number | R000025342 |
| Scientific Title | Assessment for the postgastrectomy syndrome |
| Date of disclosure of the study information | 2016/04/20 |
| Last modified on | 2016/04/19 20:30:38 |
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Basic information
Public title
Assessment for the postgastrectomy syndrome
Acronym
Assessment for the postgastrectomy syndrome
Scientific Title
Assessment for the postgastrectomy syndrome
Scientific Title:Acronym
Assessment for the postgastrectomy syndrome
Region
| Japan |
Condition
Condition
Gastric cancer without distant metastasis
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate general and nutritional condition for the postgastrectomy patients.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Post operative Quality of Life. ( One month after, One year after)
Key secondary outcomes
Post operative nutritional condition. ( One month after, One year after)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Histologically proven primary gastric cancer without distant metastasis
Key exclusion criteria
Metastasis to distant organ sites, other active concomitant malignancies, or recurrent gastric cancers.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Sasaki |
Organization
Saitama Red Cross Hospital
Division name
Department of Surgery
Zip code
Address
8-3-33, Kamiochiai, Chuo-ku, Saitama city, Saitama
TEL
048-645-1617
shsasaki@saitama-med.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Sasaki |
Organization
Saitama Red Cross Hospital
Division name
Department of Surgery
Zip code
Address
8-3-33, Kamiochiai, Chuo-ku, Saitama city, Saitama
TEL
048-645-1617
Homepage URL
shsasaki@saitama-med.jrc.or.jp
Sponsor or person
Institute
Saitama Red Cross Hospital, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Saitama Red Cross Hospital, Department of Surgery
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
さいたま赤十字病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 20 | 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
| 2015 | Year | 08 | Month | 01 | 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
Clinical stage of gastric cancer, Type of pathological character, Ages, Comorbidity, With or without chemotherapy, Type of operation and reconstruction, Operation time, Complications, PGSAS-45(PGSAS-37 + SF-8), Body Composition Analyze, etc.
Management information
Registered date
| 2016 | Year | 04 | Month | 19 | Day |
Last modified on
| 2016 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025342
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
