UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005326 |
|---|---|
| Receipt number | R000006330 |
| Scientific Title | The effect of proton pump inhibitor on quality of life after gastrointestinal surgery |
| Date of disclosure of the study information | 2011/03/28 |
| Last modified on | 2011/04/13 14:09:58 |
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Basic information
Public title
The effect of proton pump inhibitor on quality of life after gastrointestinal surgery
Acronym
The effect of PPI on QOL after GI surgery
Scientific Title
The effect of proton pump inhibitor on quality of life after gastrointestinal surgery
Scientific Title:Acronym
The effect of PPI on QOL after GI surgery
Region
| Japan |
Condition
Condition
digestive disease which is indicated for surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of lansoprazole on quality of life after digestive surgery using gastrointestinal symptom rating scale
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the difference of the effectiveness of lansoprazole 15 mg and 30 mg on quality of life after digestive surgery using gastrointestinal symptom rating scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
lansoprazole 15 mg per oral per day for 8 weeks
Interventions/Control_2
lansoprazole 30 mg per oral per day for 8 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with digestive disease whichi are indicated for surgery
Key exclusion criteria
Patients younger than 20 year old
Target sample size
690
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhiko Yanaga |
Organization
Department of Surgery,
The Jikei University School of Medicine
Division name
Gastrointestinal Surgery
Zip code
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo JAPAN
TEL
03-3433-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Gocho |
Organization
Department of Surgery,
Division name
Gastrointestinal Surgery
Zip code
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Department of Surgery,
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, the Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | 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
| 2011 | Year | 03 | Month | 28 | Day |
Last modified on
| 2011 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006330
| 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 |
