UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002999 |
|---|---|
| Receipt number | 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 15:27:58 |
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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
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
s0714@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003634
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
