UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000021356