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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001513
Receipt No. R000001817
Scientific Title Laparoscopy Versus Open Distal Gastrectomy for Early Gastric Cancer: A Randomized Controlled Trial
Date of disclosure of the study information 2013/02/20
Last modified on 2008/11/18

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Basic information
Public title Laparoscopy Versus Open Distal Gastrectomy for Early Gastric Cancer: A Randomized Controlled Trial
Acronym Laparoscopy-Assisted Distal Gastrectomy
Scientific Title Laparoscopy Versus Open Distal Gastrectomy for Early Gastric Cancer: A Randomized Controlled Trial
Scientific Title:Acronym Laparoscopy-Assisted Distal Gastrectomy
Region
Japan

Condition
Condition Early gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to compare, with the use of a randomized control trial (RCT), laparoscopy-assisted distal gastrectomy (LADG) and conventional open distal gastrectomy (ODG) for gastric cancer regarding clinical outcomes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes The short term primary outcome measure was defined as the intensity of post-operative use of analgesics. Long term primary outcome was overall survival.
Key secondary outcomes Short term secondary outcomes were intraoperative and postoperative complication rates, days of post-operative hospitalization, and post-operative inconveniences such as days of fever (> 37 degrees Celsius), days to first flatus, VAS pain scores, and blood loss.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Laparoscopy assisted distal gasterctomy
Interventions/Control_2 Open distal gastrectomy
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients were eligible for inclusion if they were over 20 years of age and under 75 and if they were diagnosed as having gastric cancer in the mid or lower parts of the stomach with indication for distal gastrectomy.
Key exclusion criteria Exclusion criteria were past history of gastric cancer, having received open surgery of the upper abdomen, past history of other types of cancers and cancer treatmentd, serious heart, lung, kidney, blood and/or metabolic diseases, Class III or IV of the New York Heart Association classification of cardiac patients, and Class III of Hugh-Jones dyspnea criteria.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Sakuramoto
Organization Kitasato University School of Medicine
Division name Department of Surgery
Zip code
Address 2-1-1 Asamizodai, Sagamihara, Kanagawa 228-8520, Japan
TEL +81-42-748-9111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Leon Bax
Organization Kitasato University School of Medicine
Division name Kitasato Clinical Research Center
Zip code
Address 1-15-1 Kitasato, Sagamihara, Kanagawa 228-8555, Japan
TEL +81-42-778-8111
Homepage URL
Email

Sponsor
Institute Kitasato University
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)

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
2013 Year 02 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 No longer recruiting
Date of protocol fixation
2005 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2005 Year 10 Month 01 Day
Last follow-up date
2008 Year 06 Month 01 Day
Date of closure to data entry
2008 Year 07 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 11 Month 18 Day
Last modified on
2008 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001817

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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