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Recruitment status Completed
Unique ID issued by UMIN UMIN000011344
Receipt No. R000009362
Scientific Title The state of postoperative taste deficit after digestive diseases
Date of disclosure of the study information 2013/08/01
Last modified on 2013/08/02

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Basic information
Public title The state of postoperative taste deficit after digestive diseases
Acronym The state of postoperative taste deficit after digestive diseases
Scientific Title The state of postoperative taste deficit after digestive diseases
Scientific Title:Acronym The state of postoperative taste deficit after digestive diseases
Region
Japan

Condition
Condition postoperative patients of digestive diseases
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 assessment of postoperative taste deficit of digestive diseases
Basic objectives2 Others
Basic objectives -Others obsevational study
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes presence of taste deficit
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria the postoperative patients of laparotomy in our department
Key exclusion criteria 1) the patients of emergency operation
2) fasting patients
3) drugs or alcohol dependece
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fuyuhiko Motoi
Organization Tohoku university hospital
devision of Hepato-Biliary Pancreatic Surgery
Division name devision of Hepato-Biliary Pancreatic Surgery
Zip code
Address Seiryocho1-1 Aobaku Sendaishi Miyagi
TEL 022-717-7205
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kudo Katsuyoshi
Organization Tohoku university hospital
Division name devision of gastrointestinal Surgery
Zip code
Address
TEL
Homepage URL
Email kykudo@surg1.med.tohoku.ac.jp

Sponsor
Institute Tohoku university hospital
devision of Hepato-Biliary Pancreatic surgery and devision of gastrointestinal surgery
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization self funding
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
Email

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

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 01 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 Completed
Date of protocol fixation
2012 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2013 Year 01 Month 01 Day
Date of closure to data entry
2013 Year 01 Month 01 Day
Date trial data considered complete
2013 Year 01 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information questionnaire survey of postooperative taste deficit

Management information
Registered date
2013 Year 08 Month 01 Day
Last modified on
2013 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009362


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