UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial to evaluate the effect of carbohydrate loading on intraoperative core temperature in patients undergoing laparoscopic resection of colon cancer
Title of the study (Brief title)	Randomized controlled trial to evaluate the effect of carbohydrate loading on intraoperative core temperature in patients undergoing laparoscopic resection of colon cancer
Region	Japan

Condition
Condition	Colon cancer(including rectosigmoid colon cancer)
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to demonstrate that carbohydrate loading prevent intraoperative hypothermia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intraoperative core temperature
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Preoperative carbohydrate loading
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Scheduled laparoscopic resection of colon cancer 2)PS0-1 3)ASA1-2
Key exclusion criteria	1)Bowel obstruction 2)Renal failure,Heart failure,and diabetes mellitus 3)On operation day,body temperature is above 37.5 centigrade scale 4)converted open surgery
Target sample size	70

Research contact person
Name of lead principal investigator	kazuhisa Uchiyama
Organization	Osaka Medical College
Division name	Department of General and Gastroenterological Surgery
Address	2-7, Digakucho, Takatuki, Osaka, Japan
TEL	072-683-1221
Email	sur154@osaka-med.ac.jp

Public contact
Name of contact person	Hiroki Hamamoto
Organization	Osaka Medical College
Division name	Department of General and Gastroenterological
Address	2-7, Digakucho, Takatuki, Osak
TEL	072-683-1221
Homepage URL
Email	hirokihamamoto@msn.com

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	None
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	2013 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 01 Day
Anticipated trial start date	2013 Year 07 Month 02 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	Published
URL releasing results	https://link.springer.com/article/10.1007%2Fs00464-018-6273-2
Results
Other related information

Management information
Registered date	2013 Year 06 Month 26 Day
Last modified on	2018 Year 12 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012934