UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008691 |
|---|---|
| Receipt number | R000010220 |
| Scientific Title | Effectiveness of bacteria reduction by irrigation of stomach with natural saline before endoscopic submucosal dissection and natural orifice transluminal endoscopic surgery |
| Date of disclosure of the study information | 2012/08/15 |
| Last modified on | 2013/12/05 22:04:04 |
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Basic information
Public title
Effectiveness of bacteria reduction by irrigation of stomach with natural saline before endoscopic submucosal dissection and natural orifice transluminal endoscopic surgery
Acronym
Relevant sterilization of endoscopic submucosal dissection and natural orifice transluminal endoscopic surgery
Scientific Title
Effectiveness of bacteria reduction by irrigation of stomach with natural saline before endoscopic submucosal dissection and natural orifice transluminal endoscopic surgery
Scientific Title:Acronym
Relevant sterilization of endoscopic submucosal dissection and natural orifice transluminal endoscopic surgery
Region
| Japan |
Condition
Condition
Early gastric cancer, Gastric gastrointestinal stromal tumor
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Infectious disease | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the bacteria reduction by irrigation with natural saline during operation (ESD/NOTES) and capability of prevention from post operative bacterial peritonitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of bacteria reduction by irrigation with natural saline during operation (ESD/NOTES)
Key secondary outcomes
WBC,CRP,BT,abdominal pain and aspiration pneumonia before and after ESD or NOTES
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Irrigation of stomach and esophagus with 2000ml natural saline before ESD and NOTES
Interventions/Control_2
No irrigation group
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Fifty patients who are diagnosed with early gastric cancer or gastric GIST and are going to undergo ESD or NOTES
Key exclusion criteria
Complications during ESD or NOTES
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mori Hirohito |
Organization
Kagawa University
Division name
Department of Gastroenterology and Neurology
Zip code
Address
1750-1, Miki, Kida, Kagawa, Japan
TEL
087-891-2156
hiro4884@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mori Hirohito |
Organization
Kagawa University
Division name
Ethical commission of Kagawa University
Zip code
Address
1750-1,Miki,Kida,Kagawa
TEL
087-891-2156
Homepage URL
hiro4884@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Kagawa University
Organization
Division
Category of Funding Organization
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
香川大学医学部 Kagawa University
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 15 | Day |
Last modified on
| 2013 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010220
