UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011749 |
|---|---|
| Receipt number | R000013738 |
| Scientific Title | Short-term outcomes and potential advantages of robotic gastrectomy for gastric cancer in comparison with conventional laparoscopic approach. |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2024/03/22 09:16:22 |
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Basic information
Public title
Short-term outcomes and potential advantages of robotic gastrectomy for gastric cancer in comparison with conventional laparoscopic approach.
Acronym
Robotic vs. laparoscopic gastrectomy for gastric cancer.
Scientific Title
Short-term outcomes and potential advantages of robotic gastrectomy for gastric cancer in comparison with conventional laparoscopic approach.
Scientific Title:Acronym
Robotic vs. laparoscopic gastrectomy for gastric cancer.
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine whether use of surgical robot reduces postoperative complications especially related to surgical maneuver.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Morbidity
Key secondary outcomes
Postoperative hospital stay
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Robotic gastrectomy
Interventions/Control_2
Laparoscopic gastrectomy
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Primary gastric cancer for which surgical treatment was applicable(cStageI-III)
Key exclusion criteria
Palliative operation: H(+), P(+), Cy(+)
Insufficient physical function (open gastrectomy, reduced extent of lymphadenectomy).
Double cancer.
Initial 10 cases for each operating surgeons.
Target sample size
650
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Uyama |
Organization
Fujita Health University
Division name
Division of Upper GI, Department of Surgery
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi
TEL
0562-93-9254
iuyama@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Suda |
Organization
Fujita Health University
Division name
Division of Upper GI, Department of Surgery
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi
TEL
0562-93-9254
Homepage URL
ko-suda@fujita-hu.ac.jp
Sponsor or person
Institute
Division of upper GI, Department of surgery, Fujita Health Univeristy
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Institutional Review Board of Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.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
藤田医科大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
526
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
Main results already published
Date of protocol fixation
| 2008 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2009 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Suda K, Man-I M, Ishida Y, Kawamura Y, Satoh S, Uyama I. Potential advantages of robotic radical gastrectomy for gastric adenocarcinoma in comparison with conventional laparoscopic approach: a single institutional retrospective comparative cohort study. Surg Endosc 2015;29:673-685.
Nakauchi M, Suda K, Shibasaki S, Kadoya S, Inaba K, Ishida Y, Uyama I. Comparison of the long-term outcomes of robotic radical gastrectomy for gastric cancer and conventional laparoscopic approach: a single institutional retrospective cohort study. Surg Endosc 2016;30:5444-5452.
Shibasaki S, Suda K, Nakauchi M, Nakamura K, Kikuchi K, Inaba K, Uyama I. Non-robotic minimally invasive gastrectomy as an independent risk factor for postoperative intra-abdominal infectious complications: A single-center, retrospective and propensity score-matched analysis. World J Gastroenterol 2020;26:1172-1184
Nakauchi M, Suda K, Shibasaki S, Kikuchi K, Kadoya S, Inaba K, Uyama I. Prognostic factors of minimally invasive surgery for gastric cancer: Does robotic gastrectomy bring oncological benefit? World J Gastroenterol 2021; 27:6659-6672.
Shibasaki S, Nakauchi M, Serizawa A, Nakamura K, Akimoto S, Tanaka T, Inaba K, Uyama I, Suda K. Clinical advantage of standardized robotic total gastrectomy for gastric cancer: A single-center retrospective cohort study using propensity-score matching analysis. Gastric Cancer 2022;25:804-816
Shibasaki S, Suda K, Hisamori S, Obama K, Terashima M, Uyama I. Robotic gastrectomy for gastric cancer: systematic review and future directions.Gastric Cancer 2023 May;26:325-338.
Management information
Registered date
| 2013 | Year | 09 | Month | 13 | Day |
Last modified on
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013738
