UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Oral intake and activities of the patients after pancreatoduodenectomy
Title of the study (Brief title)	Oral intake and activities of the patients after pancreatoduodenectomy
Region	Japan

Condition
Condition	after pancreatoduodenectomy
Classification by specialty	Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	assessment of the correlation between the oral intake calorie and the number of steps after pancreatoduodenectomy
Basic objectives2	Others
Basic objectives -Others	observational study
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	correlation between the oral intake calorie and the number of steps
Key secondary outcomes

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	85 years-old >
Gender	Male and Female
Key inclusion criteria	the patients of admission for pancreatoduodenectomy
Key exclusion criteria	the patients of cognition Disorder
Target sample size	10

Research contact person
Name of lead principal investigator	Etsuko Oyama
Organization	Tohoku university hospital
Division name	E8 ward
Address	Seiryo cho 1-1, Aobaku, Sendai, Miyagi, Japan
TEL	022-717-7205
Email	kykudo@surg1.med.tohoku.ac.jp

Public contact
Name of contact person	Kudo Katsuyoshi
Organization	Tohoku university hospital
Division name	gastrointestinal surgery
Address	Seiryo cho 1-1, Aobaku, Sendai, Miyagi, Japan
TEL	022-717-7205
Homepage URL
Email	kykudo@surg1.med.tohoku.ac.jp

Sponsor
Institute	Tohoku university hospital gastrointestinal surgery
Institute
Department

Funding Source
Organization	Tohoku university hospital gastrointestinal surgery
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

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	2014 Year 08 Month 04 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 07 Month 10 Day
Anticipated trial start date	2014 Year 07 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We measure the number of steps and walking distance of the patients by pedometer after removed ureteral catheter, after pancreatoduodenectomy. We record thier food intake and measure the intake calories. We analyze the correlation between the oral intake calorie and the number of steps.

Management information
Registered date	2014 Year 08 Month 03 Day
Last modified on	2016 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017151