UMIN-CTR Clinical Trial

Basic information
Public title	Pilot study of robot-assisted rectal cancer surgery using the da Vinci Xi Surgical System
Acronym	Pilot study of robot-assisted rectal cancer surgery
Scientific Title	Pilot study of robot-assisted rectal cancer surgery using the da Vinci Xi Surgical System
Scientific Title:Acronym	Pilot study of robot-assisted rectal cancer surgery
Region	Japan

Condition
Condition	Rectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To study of the feasibility or safety of robot-assisted rectal cancer surgery using the da Vinci Xi surgical system
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of adverse events during and after robotic surgery
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	robot-assisted rectal cancer surgery using the da Vinci Xi Surgical System
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. Localization of tumor is RS, Ra, and Rb. 2. Curability A operation is expected. 3. Patient age is more than 20 years old, less than 75 years old. 4. ECOG performance status is 0 or 1. 5. Patient is possible to take orally. 6. Informed consent by a document is acquired.
Key exclusion criteria	1. Robot-assisted surgery is difficult by the operation past, or last operation findings. 2. Severe complication(angina, myocardial infarction, severe arrhythmia, poor control diabetes mellitus, malignant hyperthermia, bleeding tendency, etc.) 3. Anemia (Hb: less than 9.0g/dl) 4. Renal disfunction (serum creatinine: more than 1.5mg/dl), 5. Liver dysfunction (AST, ALT: more than 100 IU/l) 6. Interstitial pneumonia, pulmonary fibrosis, severe emphysema 7. Severe drug sensitivity, drug allergy 8. Glaucoma 9. Post subarachnoid hemorrhage, unruptured cerebral aneurysm 10. Mental disorder 11. The attending physician decides that the patient is unfit for this surgery
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Atsushi Tsuruta
Organization	Kawasaki Medical School
Division name	Department of Digestive Surgery
Zip code
Address	577 Matsushima, Kurashiki, Okayama
TEL	086-462-1111
Email	atsuatsu@apost.plala.or.jp

Public contact
Name of contact person	1st name Middle name Last name Atsushi Tsuruta
Organization	Kawasaki Medical School
Division name	Department of Digestive Surgery
Zip code
Address	577 Matsushima, Kurashiki, Okayama
TEL	086-462-1111
Homepage URL
Email	atsuatsu@apost.plala.or.jp

Sponsor
Institute	Department of Digestive Surgery, Kawasaki Medical School
Institute
Department

Funding Source
Organization	Department of Digestive Surgery, Kawasaki Medical School
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 04 Month 01 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	Terminated
Date of protocol fixation	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 10 Month 29 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 09 Day
Last modified on	2021 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036135