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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035459
Receipt No. R000040398
Official scientific title of the study 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 2019/01/06

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Basic information
Official scientific title of the study The feasibility study of Robot-assisted gastrectomy for patients with gastric cancer
-Single institute prospective cohort study
Title of the study (Brief title) 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 Michitaka Honda
Organization Southern Tohoku General Hospital
Division name Surgery
Address Yatsuyamada 7-115, Koriyama, Fukushima
TEL 024-934-5322
Email mhonda@fukushimamed.com

Public contact
Name of contact person Michitaka Honda
Organization Southern Tohoku General Hospital
Division name Surgery
Address Yatsuyamada 7-161, Koriyama, Fukushima
TEL 024-934-5322
Homepage URL
Email mhonda@fukushimamed.com

Sponsor
Institute Southern Tohoku General Hospital
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 02 Month 22 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2019 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040398

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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