UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035459 |
|---|---|
| Receipt number | R000040398 |
| Scientific Title | The feasibility study of Robot-assisted gastrectomy for patients with gastric cancer -Single institute prospective cohort study |
| Date of disclosure of the study information | 2019/01/06 |
| Last modified on | 2021/08/17 13:50:44 |
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Basic information
Public title
The feasibility study of Robot-assisted gastrectomy for patients with gastric cancer
-Single institute prospective cohort study
Acronym
The feasibility study of Robot-assisted gastrectomy for patients with gastric cancer
Scientific Title
The feasibility study of Robot-assisted gastrectomy for patients with gastric cancer
-Single institute prospective cohort study
Scientific Title:Acronym
The feasibility study of Robot-assisted gastrectomy for patients with gastric cancer
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of feasibility of robot-assisted surgery for gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incident of postoperative complications beyond Clavien-Dindo IIIa.
Key secondary outcomes
1. All adverse events
2. Number of lymph node dissection
3. Surgical time (anesthesia time, operation time, console operation time, total time from entering operation room to leaving)
4. Bleeding volume
5. Intraoperative incident
6. Proportion of conversion to open surgery
7. Period up to the start of postoperative adjuvant chemotherapy
8. Hospitalization days
9. Cost
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients where a distal , pylorus preserving, proximal or total gastrectomy was planned, following by histologically confirmed gastric cancer (common type: pap, tub 1, tub 2, por 1, por 2, sig, muc) before surgery.
2. Patients of c Stage I gastric cancer (T1N0M0, T2N0M0, T1N1M0)
Key exclusion criteria
1. Patients with remnant stomach cancer.
2. Patients who underwent radiotherapy or other cancer treatment before surgery.
3. Patients who are required comprehensive resection of the spleen or other organs.
4. Patients who undergo large invasive surgery such as colon cancer surgery.
5. Patients who cannot obtain informed consent to participate in this study.
6. Patients with esophageal invasion
7. Patients with duodenal invasion
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michitaka Honda |
Organization
Southern Tohoku General Hospital
Division name
Surgery
Zip code
Address
Yatsuyamada 7-115, Koriyama, Fukushima
TEL
024-934-5322
mhonda@fukushimamed.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michitaka Honda |
Organization
Southern Tohoku General Hospital
Division name
Surgery
Zip code
Address
Yatsuyamada 7-161, Koriyama, Fukushima
TEL
024-934-5322
Homepage URL
mhonda@fukushimamed.com
Sponsor or person
Institute
Southern Tohoku General Hospital
Institute
Department
Personal name
Funding Source
Organization
Southern Tohoku General Hospital
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
一般財団法人脳神経疾患研究所 総合南東北病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 06 | 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
| 2018 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of feasibility of robot-assisted surgery for gastric cancer
Management information
Registered date
| 2019 | Year | 01 | Month | 06 | Day |
Last modified on
| 2021 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040398
