UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036185 |
|---|---|
| Receipt number | R000041227 |
| Scientific Title | Comparison of postoperative complication after DST and Hemi DST during Roux - en Y reconstruction at laparoscopic total gastrectomy |
| Date of disclosure of the study information | 2019/03/14 |
| Last modified on | 2019/03/14 09:36:59 |
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Basic information
Public title
Comparison of postoperative complication after DST and Hemi DST during Roux - en Y reconstruction at laparoscopic total gastrectomy
Acronym
Comparison of postoperative complication after DST and Hemi DST during Roux - en Y reconstruction at laparoscopic total gastrectomy
Scientific Title
Comparison of postoperative complication after DST and Hemi DST during Roux - en Y reconstruction at laparoscopic total gastrectomy
Scientific Title:Acronym
Comparison of postoperative complication after DST and Hemi DST during Roux - en Y reconstruction at laparoscopic total gastrectomy
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Investigate whether the incidence of postoperative stenosis varies with different anastomotic procedures
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of anastomotic stenosis
Key secondary outcomes
Occurrence of perioperative complications such as suture failure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
the Double Stapping Technique
Interventions/Control_2
the Hemidouble Stapping Technique
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
| 30 | years-old | < |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Gastric cancer patients with Stage I to III without esophageal invasion
ASA classification 1 or 2
Key exclusion criteria
Esophageal Invasion
Stage 4
ASA>2
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tetsu |
| Middle name | |
| Last name | Fukunaga |
Organization
Juntendo University
Division name
Gastro enterology and minimally invasive surgery
Zip code
113-8421
Address
2-1-1,Hongo , Bunkyoku , Tokyo , Japan
TEL
03-3813-3111
t2fukunaga@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kanda |
Organization
Juntendo University
Division name
Gastroenterology and minimally invasive surgery
Zip code
113-8421
Address
2-1-1,Hongo , Bunkyoku , Tokyo , Japan
TEL
0338133111
Homepage URL
st-kanda@juntendo.ac.jp
Sponsor or person
Institute
Gastroenterology and minimally invasive surgery , Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Gastroenterology and minimally invasive surgery , Juntendo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JPN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo Universty
Address
2-1-1,Hongo , Bunkyoku , Tokyo , Japan
Tel
0338133111
t2fukunaga@juntendo.ac.jp
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
| 2019 | Year | 03 | Month | 14 | 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
| 2019 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 13 | Day |
Last modified on
| 2019 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041227
