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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038517
Receipt No. R000043893
Scientific Title A study on the relationship between remnant stomach volume and postoperative QOL
Date of disclosure of the study information 2019/11/08
Last modified on 2019/11/07

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Basic information
Public title A study on the relationship between remnant stomach volume and postoperative QOL
Acronym A study on the relationship between remnant stomach volume and postoperative QOL
Scientific Title A study on the relationship between remnant stomach volume and postoperative QOL
Scientific Title:Acronym A study on the relationship between remnant stomach volume and postoperative QOL
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationship between remnant stomach volume and postgastrectomy syndrome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship of PGSAS-37 and remnant stomach volume
Key secondary outcomes The relationship of body composition change and remnant stomach volume

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Intravenously infuse butylscopolamine 1A (10 mg). Patients with glaucoma, benign prostatic hyperplasia use glucagon (not for patients with diabetes).
After taking 6 g of foaming agent with 10 ml of water, CT examination is performed.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Gastrectomy for gastric cancer since 2010
No recurrence for more than 1 year after surgery
Has not developed a malignant tumor within the past 5 years (excluding intramucosal cancer)
Consent is obtained in writing
Gastric resection is scheduled at this hospital
Key exclusion criteria Taking postoperative adjuvant therapy or taking medication for side effects of postoperative adjuvant therapy
Comorbidities of poor control (including insulin use and oral steroids)
Cases judged by the attending physician as ineligible
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Ryo
Middle name
Last name Tanaka
Organization Osaka Medical College
Division name Department of General and Gastroenterological Surgery
Zip code 569-8686
Address 2-7 daigaku-machi Takatsuki city, Osaka
TEL 072-683-1221
Email sur148@osaka-med.ac.jp

Public contact
Name of contact person
1st name Ryo
Middle name
Last name Tanaka
Organization Osaka Medical College
Division name Department of General and Gastroenterological Surgery
Zip code 569-8686
Address 2-7 daigaku-machi Takatsuki city, Osaka
TEL 072-683-1221
Homepage URL
Email sur148@osaka-med.ac.jp

Sponsor
Institute Department of General and Gastroenterological Surgery,
Osaka Medical College
Institute
Department

Funding Source
Organization Department of General and Gastroenterological Surgery,
Osaka Medical College
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka Medical College
Address 2-7 daigaku-machi Takatsuki city, Osaka
Tel 072-683-1221
Email sur148@osaka-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 大阪医科大学

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 08 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 Preinitiation
Date of protocol fixation
2019 Year 09 Month 03 Day
Date of IRB
2019 Year 10 Month 02 Day
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2022 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 07 Day
Last modified on
2019 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043893

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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