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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002999
Receipt No. R000003634
Scientific Title Usefulness of Harmonic Scalpel FOCUS for open distal gastrectomy in patients with gastric cancer
Date of disclosure of the study information 2010/01/20
Last modified on 2013/04/02

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Basic information
Public title Usefulness of Harmonic Scalpel FOCUS for open distal gastrectomy in patients with gastric cancer

Acronym Usefulness of Harmonic Scalpel FOCUS for open distal gastrectomy in patients with gastric cancer

Scientific Title Usefulness of Harmonic Scalpel FOCUS for open distal gastrectomy in patients with gastric cancer

Scientific Title:Acronym Usefulness of Harmonic Scalpel FOCUS for open distal gastrectomy in patients with gastric cancer

Region
Japan

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

Objectives
Narrative objectives1 To clarify the usefulness of Harmonic Scalpel FOCUS
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Intraoperative factors: Blood loss, Operation time, Blood transfusion, The number of used sponged gauze
Pestoperative factors: Lymphorrhea, Pancreatic fistula, Discharge from the drain

Key secondary outcomes

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 Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Harmonic Group: Operation is performed by using Harmonic Scalpel FOCUS. When dividing the main vessels, the strings can be used.
Interventions/Control_2 Non-Harmonic group: Operation is performed by the strings alone.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with resectable gastric cancer are included in this study. There is no limitation for age and gender.
Key exclusion criteria 1. past history of abdominal surgery
2. patients who have co-morbid disease with bleeding tendency
3. patients who did not give informed consent
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chikara Kunisaki
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code
Address 4-57, Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email

Public contact
Name of contact person
1st name
Middle name
Last name Chikara Kunisaki
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code
Address 4-57, Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email s0714@med.yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
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 横浜市立大学附属市民総合医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2010 Year 01 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 Completed
Date of protocol fixation
2009 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 08 Day
Last modified on
2013 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003634

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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