UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011924 |
|---|---|
| Receipt number | R000013921 |
| Scientific Title | comparison gastrointestinal function between laparoscopy total gastrectomy and laparoscopy proximal gastrectomy with double tract reconstruction. |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2018/10/04 09:25:49 |
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Basic information
Public title
comparison gastrointestinal function between laparoscopy total gastrectomy and laparoscopy proximal gastrectomy with double tract reconstruction.
Acronym
comparison gastrointestinal function between laparoscopy total gastrectomy and laparoscopy proximal gastrectomy with double tract reconstruction.
Scientific Title
comparison gastrointestinal function between laparoscopy total gastrectomy and laparoscopy proximal gastrectomy with double tract reconstruction.
Scientific Title:Acronym
comparison gastrointestinal function between laparoscopy total gastrectomy and laparoscopy proximal gastrectomy with double tract reconstruction.
Region
| Japan |
Condition
Condition
Gastric cancer patients after gastrectomy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the gastrointestinal function of post gastrectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
questionnaire about postoperative quality of life
Key secondary outcomes
each examination of postoperative quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
evaluate the gastrointestinal function of patients who underwent double tract recostruction after laparoscopy proximal gastrectomy for gastric cancer.
Interventions/Control_2
evaluate the gastrointestinal function of patients who underwent Roux-en-Y recostruction after laparoscopy total gastrectomy for gastric cancer.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. patient who underwent laparoscopy total gastrectomy with Roux-en-Y recnstruction or laparoscopy proximal gastrectomy with double tract reconstruction for early gastric cancer
2. curative resection and free from recurrence
3. for one year after treatment
4. Age>20 and <80 years
5. possible to intake orally
6. written informed consent
Key exclusion criteria
1. open procedure
2. except for laparoscopy total or proximal gastrectomy
3. with severe complication or active dual malignancy
4. judged as inappropriate by physician-in-charge
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Syuji Takiguchi |
Organization
Osaka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka Suita City Osaka
TEL
06-6879-3251
stakiguchi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Gakuhara |
Organization
Osaka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka Suita City Osaka
TEL
06-6879-3251
Homepage URL
agakuhara@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University School of Medicine Gastroenterological Surgery
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 01 | 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
| 2013 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 02 | 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
| 2013 | Year | 10 | Month | 01 | Day |
Last modified on
| 2018 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013921
