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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003841
Receipt No. R000004627
Scientific Title A multicenter randomized double blind test of the effect of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopic cholecystectomy
Date of disclosure of the study information 2010/06/29
Last modified on 2014/12/23

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Basic information
Public title A multicenter randomized double blind test of the effect of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopic cholecystectomy
Acronym A multicenter randomized double blind test of the effect of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopic cholecystectomy
Scientific Title A multicenter randomized double blind test of the effect of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopic cholecystectomy
Scientific Title:Acronym A multicenter randomized double blind test of the effect of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopic cholecystectomy
Region
Japan

Condition
Condition Diseases in the gallbladder
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the preventive efficacy of dexamethasone for post operative nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The incidence of post operative nausea and vomiting (PONV)
Key secondary outcomes Postoperative complications, Postoperative hospital stay, Medical cost

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravenous administration of dexamethasone (8mg) just before cholecystectomy
Interventions/Control_2 Intravenous administration of saline just before cholecystectomy
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
80 years-old >
Gender Male and Female
Key inclusion criteria (1) Patient undergoing laparoscopic cholecystectomy
(2) Age between 20 and 79
(3) Adequate hematologic, hepatic, renal and respiratory function
(4) Written informed consent
Key exclusion criteria (1) Emergency surgery
(2) Patient who had undergone upper abdominal surgery
(3) Patient who is expected to convert into open surgery
(4) Continuous use of steroid
(5) ASA>3
(6) Day surgery
(7) Treatment with opioid or tranquilizer within 1 week
(8) Clinically significant cardiac or respiratory dysfunction
(9) Severe mental disorder
(10) Contraindication for dexamethasone
(11) As determined by the principal investigator or the sub-investigator the subject is not adequate to participate in the trial
Target sample size 270

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Nagano
Organization Osaka University Graduate school of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3251
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hidetoshi Eguchi
Organization Osaka University Graduate school of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3251
Homepage URL
Email heguchi@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Multicenter Clinical Study Group of Osaka
Institute
Department

Funding Source
Organization None (Self-funding)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 29 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 Completed
Date of protocol fixation
2010 Year 02 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2013 Year 06 Month 19 Day
Date of closure to data entry
2013 Year 06 Month 19 Day
Date trial data considered complete
2013 Year 08 Month 01 Day
Date analysis concluded
2013 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 29 Day
Last modified on
2014 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004627

Research Plan
Registered date File name
2014/12/24 CSGO-HBP-002_LC後デキサメサゾン_プロトコル.docx

Research case data specifications
Registered date File name
2014/12/24 CSGO-HBP-002_LC後デキサメサゾン_CRF.docx

Research case data
Registered date File name


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