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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027135
Receipt No. R000031094
Scientific Title The study of the resting energy metabolism and stress factor using an indirect calorimeter in the perioperative period of endoscopic operation
Date of disclosure of the study information 2017/04/26
Last modified on 2022/05/04

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Basic information
Public title The study of the resting energy metabolism and stress factor using an indirect calorimeter in the perioperative period of endoscopic operation
Acronym invasiveness of endoscopic operation
Scientific Title The study of the resting energy metabolism and stress factor using an indirect calorimeter in the perioperative period of endoscopic operation
Scientific Title:Acronym invasiveness of endoscopic operation
Region
Japan

Condition
Condition gactric cancer, colorectal cancer, esophageal cancer, esophageal achalasia
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 invasiveness of endoscopic operation
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes resting energy expenditure and the stress factor on endoscopic operation postoperative day 1
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)patients who undergo endoscopic operation
2)written informed concent
Key exclusion criteria patients with cirrhosis of the liver, respiratory disease, or who are recieving dialysis or treatment of other malignant tumor
Target sample size 75

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Chinda
Organization Hirosaki University Graduate School of Medicine
Division name Department of Gastroenterology and Hematology
Zip code 036-8562
Address 5 Zaifu-cho, Hirosaki, Aomori
TEL 0172-33-5111
Email donkeyra3@yahoo.co.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Chinda
Organization Hirosaki University Graduate School of Medicine
Division name Department of Gastroenterology and Hematology
Zip code 036-8562
Address 5 Zaifu-cho, Hirosaki, Aomori
TEL 0172-33-5111
Homepage URL
Email donkeyra3@yahoo.co.jp

Sponsor
Institute Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
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 Hirosaki University Graduate School of Medicine
Address 5 Zaifu-cho, Hirosaki, Aomori
Tel 0172-33-5111
Email donkeyra3@yahoo.co.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

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 26 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/28955134
Number of participants that the trial has enrolled
Results The stress factor on the postoperative day 1 by gastric and colorectal ESD increased significantly. However, they were low in comparison to that experienced for surgery, suggesting that the degree of perioperative invasiveness in patients receiving ESD is lower in comparison to that during surgery.
Results date posted
2020 Year 04 Month 17 Day
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 Enrolling by invitation
Date of protocol fixation
2013 Year 04 Month 05 Day
Date of IRB
2013 Year 05 Month 15 Day
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients who undergo endoscopic therapy
for gactric cancer, colorectal cancer, esophageal cancer and esophageal achalasia at Hirosaki University Hospital.

Management information
Registered date
2017 Year 04 Month 26 Day
Last modified on
2022 Year 05 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031094

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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