UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018531
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kinami@kanazawa-med.ac.jp

Sponsor
Institute kanazawa Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021356

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.