UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of preoperative oral rehydration therapy on circulatory collapse during anesthetic induction.
Title of the study (Brief title)	Efficacy of preoperative oral rehydration therapy
Region	Japan

Condition
Condition	The patients who plan to undergo resection of colorectal cancer.
Classification by specialty	Gastrointestinal surgery Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluate the effect of preoperative oral rehydration therapy on circulatory collapse during anesthetic induction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of SVV, SVI after epidural administration of 2% lidocaine
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	taking rehydration solution at most 1000ml two hours prior to surgery
Interventions/Control_2	control
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	The patients who plan to undergo resection of colorectal cancer.
Key exclusion criteria	Gastrointestinal dysfunction due to functional, non-mechanical inhibition of propulsive bowel activity
Target sample size	70

Research contact person
Name of lead principal investigator	Makiko Komori
Organization	Tokyo Women's Medical University Medical Center East
Division name	Department of Anesthesiology
Address	2-1-10 Nishiogu, Arakawa-ku, Tokyo
TEL	81-3-3810-1111
Email	komorim@nifty.com

Public contact
Name of contact person	Junko Ichikawa
Organization	Tokyo Women's Medical University Medical Center East
Division name	Department of Anesthesiology
Address	2-1-10 Nishiogu, Arakawa-ku, Tokyo
TEL	81-3-3810-1111
Homepage URL
Email	htwfx872@yahoo.co.jp

Sponsor
Institute	Tokyo Women's Medical University Medical Center East
Institute
Department

Funding Source
Organization	Budget for Anesthesiology department
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	2015 Year 12 Month 15 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 06 Month 06 Day
Anticipated trial start date	2015 Year 12 Month 15 Day
Last follow-up date	2017 Year 02 Month 10 Day
Date of closure to data entry	2017 Year 10 Month 31 Day
Date trial data considered complete	2017 Year 10 Month 31 Day
Date analysis concluded	2017 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 09 Day
Last modified on	2017 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023254