UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002910 |
|---|---|
| Receipt number | R000003547 |
| Scientific Title | laparoscopic-endoscopic cooperative surgery for stomach, duodenum and intestine |
| Date of disclosure of the study information | 2009/12/17 |
| Last modified on | 2009/12/16 18:59:22 |
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Basic information
Public title
laparoscopic-endoscopic cooperative surgery for stomach, duodenum and intestine
Acronym
laparoscopic-endoscopic cooperative surgery
Scientific Title
laparoscopic-endoscopic cooperative surgery for stomach, duodenum and intestine
Scientific Title:Acronym
laparoscopic-endoscopic cooperative surgery
Region
| Japan |
Condition
Condition
cancer,adenoma,SMT,cartinoid
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To show a surgical approach to remove stomach, duodenal and intestinal lesions using laparoscopic-endoscopic cooperative surgery (LECS) is minimally invasive and achieved excellent outcome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
morbidity,mortality,the duration of hospital stay,survival
Key secondary outcomes
patient satisfaction
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
patient who has stomach or duodenal or intestinal lesion
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patient who has stomach or duodenal or intestinal lesion
Key exclusion criteria
patient who cannot be given general anesthesia
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koide Naohiko |
Organization
Shinshu University School of Medicine
Division name
Department of Digestive Surgery
Zip code
Address
3-1-1, Asahi, Matsumoto City, 390-8621, Nagano Prefecture, Japan.
TEL
0263-37-2654
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakon Masahiro |
Organization
Shinshu University School of Medicine
Division name
Department of Digestive Surgery
Zip code
Address
3-1-1, Asahi, Matsumoto City, 390-8621, Nagano Prefecture, Japan.
TEL
0263-37-2654
Homepage URL
http://wwwhp.md.shinshu-u.ac.jp/
sakon@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Digestive Surgery Shinshu University School of Medicine,
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
信州大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 17 | Day |
Related information
URL releasing protocol
http://wwwhp.md.shinshu-u.ac.jp/
Publication of results
Unpublished
Result
URL related to results and publications
http://wwwhp.md.shinshu-u.ac.jp/
Number of participants that the trial has enrolled
Results
The postoperative course was uneventful
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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2009 | Year | 12 | Month | 16 | Day |
Last modified on
| 2009 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003547
