UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002910
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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/
Email sakon@shinshu-u.ac.jp

Sponsor
Institute Department of Digestive Surgery Shinshu University School of Medicine,
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003547

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.