UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018531 |
|---|---|
| Receipt number | R000021356 |
| Scientific Title | A cohort study of risk factors associated with postgastrectomy syndrome. |
| Date of disclosure of the study information | 2015/08/10 |
| Last modified on | 2020/02/05 13:26:52 |
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Basic information
Public title
A cohort study of risk factors associated with postgastrectomy syndrome.
Acronym
Study for risk factors associated with postgastrectomy syndrome.
Scientific Title
A cohort study of risk factors associated with postgastrectomy syndrome.
Scientific Title:Acronym
Study for risk factors associated with postgastrectomy syndrome.
Region
| Japan |
Condition
Condition
postgastrectomized patients
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyse the postgastrectomy symptoms in patients using a questionnaire, 'PGSAS-37,' and verify hypotheses that nutrition guidance improves postgastrectomy symptoms and quality of life (QOL) in patients who undergo the standard gastrectomy, QOL is maintained in function-preserving curative gastrectomy, and adjuvant chemotherapy after surgery aggravates postgastrectomy symptoms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To survey the states of QOL and postgastrectomy symptoms in all the patients who undergo gastrectomy at our hospital during a certain period of time, and clarify the effects of each intervention of nutrition guidance/surgical procedures /chemotherapy on postgastrectomy symptoms.
Key secondary outcomes
To perform differential analysis of the effects of age, sex, weight, body mass index (BMI), stage of gastric cancer, size of the remnant stomach, anastomosis, surgical approaches, reconstruction methods, presence of vagal saving, presence of comorbid disease, etc. on the QOL and postgastrectomy symptoms. Similar to various previous studies, the relationships of combinations of collected information are analysed in this study.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All the patients who underwent gastrectomy since 2008 as well as those who will undergo until 2022 at our hospital
Key exclusion criteria
patients who underwent combined resection for the other malignancy.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takeo |
| Middle name | |
| Last name | Kosaka |
Organization
Kanazawa Medical University
Division name
Dept. of Surgical Oncology
Zip code
920-0293
Address
1-1 Daigaku Uchinada Kahoku Ishikawa
TEL
0762862211
kinami@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Kinami |
Organization
Kanazawa Medical University
Division name
Dept. of Surgical Oncology
Zip code
0293
Address
1-1 Daigaku Uchinada Kahoku Ishikawa
TEL
0762862211
Homepage URL
kinami@kanazawa-med.ac.jp
Sponsor or person
Institute
kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University
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
Kanazawa Medical University
Address
1-1 Daigaku Uchinada
Tel
0762862211
kinami@kanazawa-med.ac.jp
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
金沢医科大学病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a survey of postgastrectomy symptoms and living conditions using a self-completion questionnaire. The questionnaire to be used is PGSAS-37.
Management information
Registered date
| 2015 | Year | 08 | Month | 03 | Day |
Last modified on
| 2020 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021356
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
