UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013705
Receipt No. R000015999
Scientific Title Evaluation of a perioperative management method for the purpose of fast postoperative recovery
Date of disclosure of the study information 2014/04/20
Last modified on 2014/07/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of a perioperative management method for the purpose of fast postoperative recovery
Acronym Perioperative management evaluation
Scientific Title Evaluation of a perioperative management method for the purpose of fast postoperative recovery
Scientific Title:Acronym Perioperative management evaluation
Region
Japan

Condition
Condition Esophageal Cancer
Classification by specialty
Gastrointestinal surgery Anesthesiology Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Achievement of rehabilitation (walking distance), the nutrient state of the day 30 post hospital discharge, postoperative complications, length of hospital stay, the total amount of fluids administered intra- and postoperatively.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Speed of the postoperative recovery of gastro-intestinal function (daily observation of movement of the contrast agent on a gastrography).
Key secondary outcomes Achievement of rehabilitation (walking distance), the nutrient state of the day 30 post hospital discharge, postoperative complications, length of hospital stay, the total amount of fluids administered intra- and postoperatively.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 When Stroke Volume Index (SVI) value stays in the range of +/- 10% or the target value, though blood pressure decreases, vasopressor is to be administered.When SVI value decreases by more than 10% of its target value, inotrope or vasodilator are to be administered.When SVI increased by more than 10% of its target value, diuretics is to be administered.
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. ASA-PS class is I or II
2. Patients undergo esophagectomy
3. Patients who can sign the consent form by him/herself.
Key exclusion criteria 1.Patients with disease histories of ischemic heart disease and/or ischemic brain injury
2.Patients with coagulopathy and/or renal dysfunction
3.Pateints who need blood transfusion preoperatively
4.Patients who have difficulty in walking preoperatively
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Taniguchi
Organization Kanagawa University of Human Services
Division name Faculty of Health and Human services
Zip code
Address Heisei-Cho 1-10-1, Yokosuka, Kanagawa, Japan 238-8522
TEL +81-46-828-2500
Email hstani@aol.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Taniguchi
Organization Kanagawa University of Human Services
Division name Faculty of Health and Human services
Zip code
Address Heisei-Cho 1-10-1, Yokosuka
TEL +81-46-828-2500
Homepage URL
Email hstani@aol.jp

Sponsor
Institute Kanagawa University of Human Services
Institute
Department

Funding Source
Organization Kanagawa University of Human Services
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization japan

Other related organizations
Co-sponsor Kanagawa Cancer Center
Name of secondary funder(s) Edwards Lifesciences Limited

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 神奈川県立がんセンター
神奈川県立保健福祉大学

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 20 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 Enrolling by invitation
Date of protocol fixation
2014 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 25 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2016 Year 01 Month 31 Day
Date analysis concluded
2016 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 04 Month 13 Day
Last modified on
2014 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015999

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.