UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the safety of a robot assisted operation using 'da Vinci Xi' for stomach and colorectal cancer.
Title of the study (Brief title)	Study of the safety of a robot assisted operation using 'da Vinci Xi' for stomach and colorectal cancer.
Region	Japan

Condition
Condition	stomach and colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Study of the safety of a robot assisted operation using 'da Vinci Xi' for stomach and colorectal cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Age, sex, height, weight, BMI, PS 2. Past medical history:Health history, operation history 3. laboratory test values 4. pathological classification associated tumor, number of lymph nodes harvested, venous invasion 5. Operative information procedure, reconstruction method, anesthesia time, surgical time, operative bleeding loss, Lymph node dissection number, completed in robot-assisted laparoscopic surgery, the reason of unsuccessful completion 6. Intraoperative and postoperative stomach cancer complication 7. Intraoperative and postoperative colorectal cancer complication 8. presence or absence of post-operation treatment and relapse, post-operation treatment of a therapeutic regimen, survival period, the start time of oral ingestion after operation, postoperative length of stay 9. The number of robot-assisted implemented, analysis of the operation time
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	A robot assisted operation using 'da Vinci Xi' period of ntervention: 5 years
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Histologically confirmed as being stomach and colorectal cancer 2. Pre-operation test diagnosed as stomach and colorectal cancer which can be resected curatively 3. Patients diagnosed as cannot be applied to ESD 4. ECOG performance status scale: 0 or 1, ASA: 1 or 2 5. Age <=20 years old to >=75 6. Written informed consent is obtained
Key exclusion criteria	1. Anemic condition (hemoglobin >10g/dl) 2. The patient who has active multiple cancers 3. Long-term administration of steroids 4. Patients with psychiatric diseases 5. With uncontrolled diabetes composition 6. With uncontrolled hypertension composition 7. With respiratory disorder that need continuous supply supplemental oxygen composition 8. With central nervous system disease composition (intracranial disease) 9. With glaucomatous composition 10. The patient who pose a risk for developing intracranial hypertension by head- tilt Other conditions judged ineligible by physician
Target sample size	60

Research contact person
Name of lead principal investigator	Masaki Kitazono
Organization	Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital
Division name	Surgery / Gastrointestinal surgery
Address	14-3 Nagata-cho, Kagoshima-city, Japan
TEL	0992269111
Email	m-kitazono@nanpuh.or.jp

Public contact
Name of contact person	clinical research coordinater
Organization	Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital
Division name	Clinical Research Support Office
Address	14-3 Nagata-cho, Kagoshima-city, Japan
TEL	0992269111
Homepage URL
Email	crc-kenkyu@nanpuh.or.jp

Sponsor
Institute	Public Interest Incorporated Association, Kagoshima, Nanpuh Hospital
Institute
Department

Funding Source
Organization	Public Interest Incorporated Association, Kagoshima, Nanpuh 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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 25 Day
Anticipated trial start date	2016 Year 01 Month 08 Day
Last follow-up date	2018 Year 07 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

Management information
Registered date	2016 Year 08 Month 31 Day
Last modified on	2018 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026828